Our mission is to detect cancer early, when it can be cured.
−Removed: We are an innovative commercial-stage healthcare company focused on saving lives and shifting the paradigm in early cancer detection.
+Added: We are an innovative commercial-stage healthcare company focused on shifting the paradigm in early cancer detection at population scale.
We believe screening individuals for many types of cancer with a single test represents a significant opportunity to reduce the global burden of cancer.
−Removed: Our Galleri test is a commercially available screening test for early detection of multiple types of cancer, which we termed multi-cancer early detection (“MCED”).
−Removed: We believe Galleri is clinically validated based on the results of its clinical studies completed to date, including the results of its foundational case-control Circulating Cell-free Genome Atlas (“CCGA”) study and interventional PATHFINDER study, which together enrolled more than 21,000 participants.
−Removed: In these studies, Galleri demonstrated an ability to detect a shared cancer signal through analysis of cell-free DNA in the bloodstream, accurately predict the specific organ or tissue type where the cancer signal originated, and yield high positive predictive values and low false positive rates, all from a simple blood draw.
−Removed: Galleri results can help guide next steps for a diagnosis of cancer by healthcare providers in required follow-up diagnostic testing.
−Removed: We launched Galleri in the United States in mid-2021.
−Removed: As of December 31, 2024, we have sold more than 290,000 commercial tests, more than 137,000 of which were sold in 2024, and established commercial partnerships with stakeholders including leading healthcare systems, employers, payors, and life insurance providers.
−Removed: Commercial use of Galleri has detected some of the most aggressive cancers in early stages including, among others, endometrial, esophageal, gastrointestinal, head and neck, liver, pancreatic, and rectal cancers.
+Added: Our multi-cancer early detection test (“Galleri”) can screen for many types of cancer, accurately predicting the specific organ or tissue type where the cancer signal originated (the “Cancer Signal of Origin”, or “CSO”), with high positive predictive values (“PPV”) and low false positive rates, all from a simple blood draw.
+Added: Galleri has detected some of the most aggressive cancers in early stages including, among others, endometrial, esophageal, gastrointestinal, head and neck, liver, pancreatic, and rectal cancers.
+Added: We have conducted what we believe is the largest clinical program in genomic medicine to date with data from over 385,000 participants that we believe demonstrate the clinical validation and clinical utility of Galleri in its intended use population.
+Added: We have deep operational experience with over 800,000 tests processed across this clinical program and from our commercial experience, including through partnerships with leading healthcare systems, employers, digital health platforms, payors, and life insurance providers.
+Added: Recently we announced results from two of our large clinical trials, PATHFINDER 2 and NHS-Galleri Trial, and included certain results from those studies in our pre-market approval application (“PMA”) to the Food and Drug Administration (“FDA”), the last module of which we submitted in January 2026.
+Added: Performance and safety data focused on the first approximately 25,000 participants of our approximately 35,000 participant PATHFINDER 2 study were presented at the European Society for Medical Oncology (“ESMO”) in October 2025 (the “PATHFINDER 2 Initial Results”) and demonstrated that adding Galleri to recommended (breast, cervical, colorectal and lung) screenings led to a cancer detection rate more than seven-fold increase in the number of cancers found within a year, and an approximately three-fold increase when prostate screening was included.
+Added: Results from the full approximately 35,000 participants in the PATHFINDER 2 study were generally consistent with the results presented at ESMO.
+Added: We also announced topline results from our three year, randomized control NHS-Galleri Trial which demonstrated a substantial reduction in stage 4 cancer diagnoses (including greater than 20% reduction in the second and third screening rounds), increased stage 1 and 2 detection of deadly cancers, and four-fold higher cancer detection rate when compared to recommended screenings alone.
+Added: The primary endpoint of statistically significant combined stage 3 and 4 reduction was not observed.
+Added: However, there was a favorable trend toward fewer combined stage 3 and 4 cancers in a pre-specified group of 12 deadly cancers in the intervention arm after the prevalent screening round.
+Added: The PATHFINDER 2 Initial Results and the performance and safety metrics from the first year (prevalent screening round) of our NHS-Galleri Trial (“NHS-Galleri Prevalent Screening Round Results”) were included in our PMA submission, along with results of a bridging study.
Cancer is a major public health crisis.
−Removed: It is the second leading cause of death both in the United States and worldwide.
+Added: It is a leading cause of death both in the United States and worldwide.
Most cancers that result in death are diagnosed too late, in advanced stages when they are most challenging to treat.
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Grade C recommendations are services that USPSTF recommends selectively offering or providing to patients based on individual circumstances and that have a moderate certainty of a small net benefit for patients.
−Removed: According to data in the American Cancer Society’s Cancer Facts & Figures 2025, cancers for which there are grade A and B recommendations published by the USPSTF (breast, cervical, colorectal, and lung cancer) are expected to result in approximately 225,000 deaths out of approximately 618,000 cancer-related deaths in the United States in 2025, and prostate cancer is expected to result in approximately 36,000 additional deaths.
We believe that expanding upon these current guidelines to screen individuals for many types of cancer with a single test represents a significant opportunity to reduce cancer mortality and the cost of cancer care.
In 2021, we published modeling data in Cancer Epidemiology, Biomarkers & Prevention (Cancer Epidemiol Biomarkers Prev.
−Removed: 30:460–8) that estimated the potential impact of MCED testing on mortality reduction based on test performance in our CCGA-2 study and using 2006 to 2015 data from the Surveillance, Epidemiology, and End Results Program of the U.S.
+Added: 30:460–8) that estimated the potential impact of Multi-Cancer Early Detection (“MCED”) testing on mortality reduction based on test performance in our foundational case-control Circulating Cell-free Genome Atlas (“CCGA”) study and using 2006 to 2015 data from the Surveillance, Epidemiology, and End Results Program of the U.S.
National Cancer Institute (“SEER”) for ages 50-79.
−Removed: Based on this model, we estimated that by adding Galleri to the five standard of care single-cancer screening tests (breast, cervical, colorectal, lung cancer, and prostate), there is potential to detect many more cancers at an earlier stage, which could translate into the potential to avert approximately 100,000 deaths per year in the United States as measured by five-year survival.
+Added: Based on this model, we estimated that by adding
+Added: Galleri to the five standard of care single-cancer screening tests (breast, cervical, colorectal, lung cancer, and prostate), there is potential to detect many more cancers at an earlier stage, which could translate into the potential to avert approximately 100,000 deaths per year in the United States as measured by five-year survival.
We believe this model provides helpful context regarding the potential benefits of screening for multiple cancers at once with a singular screening test, like Galleri, in addition to the five standard of care single-cancer screening tests;
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2(30):2–16) estimated that diagnosing cancer early could result in $26 billion in annual cost-savings in the United States.
−Removed: We designed Galleri to detect cancer early.
−Removed: If cancer is detected early, it is more amenable to curative treatment.
−Removed: According to the American Cancer Society, the ability to cure cancer depends on the type and stage of
−Removed: cancer, the type of treatment the patient receives, and other factors.
−Removed: While there is not one cure for cancer and not all cancers may be cured, according to the World Health Organization many cancers can be cured if detected early and treated effectively and some of the most common cancer types, such as breast cancer, cervical cancer, oral cancer, and colorectal cancer, have high cure probabilities when detected early and treated according to best practices.
+Added: We designed Galleri to detect cancer early, when it is more amenable to curative treatment.
Galleri works by detecting DNA fragments shed into the bloodstream by tumor cells.
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In our CCGA study, Galleri identified a shared cancer signal across more than 50 types of cancer, often at an early stage.
−Removed: If a cancer signal is detected, Galleri can accurately predict the tissue type or organ associated with the cancer signal (the cancer signal origin).
−Removed: In our PATHFINDER study, Galleri correctly predicted the first or second cancer signal origins in 22 of 25 participants with a cancer diagnosis following a cancer signal detected (positive) test result (i.e., participants with true positive test results), demonstrating a high cancer signal origin prediction accuracy.
+Added: If a cancer signal is detected, Galleri can accurately predict the tissue type or organ associated with the cancer signal (the CSO).
+Added: In the PATHFINDER 2 Initial Results, Galleri correctly predicted the CSO in 122 of 133 participants with a cancer diagnosis following a cancer signal detected (positive) test result (i.e., participants with true positive test results), demonstrating a high CSO prediction accuracy.
Galleri’s screening test results can be used by healthcare providers to guide required follow-up diagnostic testing for a diagnosis of cancer.
As an early pioneer of MCED testing, we have established strong relationships within the cancer and primary care community, including through partnerships with academic and community medical centers, key opinion leaders, and governmental policy and advocacy partners.
−Removed: We have shared evidence supporting our MCED testing at renowned medical conferences, such as the American Association of Cancer Research (“AACR”), American Society of Clinical Oncology (“ASCO”), European Society of Medical Oncology (“ESMO”), and American Academy of Family Physicians (“AAFP”).
+Added: We have shared evidence supporting our MCED testing at renowned medical conferences, such as the American Association of Cancer Research (“AACR”), American Society of Clinical Oncology (“ASCO”), ESMO, and American Academy of Family Physicians (“AAFP”).
We have also published results from our studies in leading scientific and medical journals, including The Lancet, Nature, Nature Medicine, Cancer Cell, and The Lancet Oncology.
−Removed: Our industry leadership has been recognized with multiple national high profile accolades, including being acknowledged by Time Magazine as one of the Best Inventions of 2022 and The Atlantic as one of the top breakthroughs of 2022, and being named in Fast Company World Changing Ideas of 2022 and in the Fortune Change the World List in 2023.
−Removed: We plan to pursue U.S.
−Removed: Food and Drug Administration (the “FDA”) approval to help support broad access for Galleri in the United States.
+Added: Our industry leadership has been recognized with multiple national high profile accolades.
+Added: In January 2026, we submitted a PMA to the FDA to help support broad access for Galleri in the United States.
Galleri is not a diagnostic test and has not been approved or cleared by the FDA.
−Removed: We plan to complete a premarket approval application (“PMA”) submission with the FDA in the first half of 2026.
−Removed: We seek to use data from the NHS-Galleri Trial, together with data from our PATHFINDER 2 study, as well as supplemental data from other clinical studies, to support our planned PMA submission for Galleri in the United States.
+Added: Our PMA submission package includes the NHS-Galleri Prevalent Round Results, together with data from the PATHFINDER 2 Initial Results.
+Added: Our PMA submission package also includes a bridging analysis to compare performance of the version of Galleri used in the NHS-Galleri Trial and PATHFINDER 2 study to the updated version for which we are seeking approval (the “Bridging Analysis”).
We believe that FDA approval could unlock broad coverage by large commercial payors in the United States.
−Removed: We have established private reimbursement for Galleri from a number of third-party payors, including self-insured employers, in the United States, but do not currently have broader coverage and reimbursement by government healthcare programs, such as Medicare.
−Removed: We are working with stakeholders to advance and shape the public reimbursement landscape to cover MCED screening for FDA-approved MCED tests.
−Removed: Galleri has not been approved or cleared by the FDA and obtaining PMA approval can take several years from the time a premarket application is submitted.
−Removed: Moreover, the FDA requirements that will govern MCED tests, as well as the breadth and nature of data we must provide the FDA to support the proposed intended use, may be subject to change, and as such it is difficult to predict what information we will need to submit to obtain approval of a PMA from the FDA for a proposed intended use.
−Removed: Following FDA approval, we also expect to pursue inclusion of Galleri in the USPSTF’s guideline recommendation, although such inclusion is not certain even with FDA approval.
−Removed: In the United Kingdom, we are working with NHS England to complete our NHS-Galleri Trial.
−Removed: NHS England will evaluate the final results from the NHS-Galleri Trial, which are expected to be available in 2026, before determining whether to implement the Galleri test in the NHS.
+Added: We have established private reimbursement for Galleri from a number of third-party payors in the United States, including self-insured employers, but do not currently have broader coverage and reimbursement by government healthcare programs, such as Medicare.
+Added: In February 2026 a new law created a Medicare coverage benefit category for MCED tests.
+Added: The law included certain standards, including that Centers for Medicare and Medicaid Services (“CMS”) would establish coverage through a national coverage determination (“NCD”) process under “reasonable and necessary” evidentiary requirements.
+Added: An NCD typically involves a multi-step review that can include evidence assessment by CMS staff, consultation with external technology assessment organizations, a Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) meeting, and opportunities for public comment.
+Added: CMS may issue an NCD to provide coverage for MCED tests that are cleared under 510(k), classified under 513(f)(2) or approved by the FDA, with authority to initiate coverage as early as January 1, 2029, although any NCD may be delayed or be more restrictive than the full authority provided by statute.
+Added: Coverage eligibility is phased in, with those aged 50-65 eligible under the law in 2029, expanding by one age-year annually.
+Added: No version of Galleri has been approved or cleared by the FDA and obtaining PMA approval can take several years from the time an application is submitted.
+Added: Galleri may not be approved on our expected timeline or at all.
+Added: If FDA approval is obtained, we also expect to pursue inclusion of Galleri in the USPSTF’s guideline recommendation, although such inclusion is not certain even with FDA approval and may take several years.
+Added: In the United Kingdom, NHS England (which is being merged with the Department of Health and Social Care) (the “NHS”) will evaluate the final results from the NHS-Galleri Trial before determining whether to implement the Galleri test in the NHS.
+Added: We plan to share final results from the full three year NHS-Galleri trial in mid-2026.
We believe the decision may include, in addition to an evaluation of the final results, considerations such as NHS budget, political priorities, cost-effectiveness and implementation constraints.
−Removed: We also believe our work with the NHS and the data generated from our NHS-Galleri Trial, if compelling, could help facilitate adoption in other single-payor systems around the world and support evidence of clinical utility worldwide.
+Added: Under our agreement with the NHS, these results have met certain success criteria and missed others.
+Added: As a result, we and NHS England will convene meetings of our joint steering committee to discuss how best to proceed with deployment to the UK population, if at all, considering deployment approaches and which population groups would most benefit.
+Added: We also believe our work with the NHS and the data generated from our NHS-Galleri Trial could help facilitate adoption in other single-payor systems around the world and support evidence of clinical utility worldwide.
+Added: We believe the evidence of clinical utility from the trial, particularly the stage 4 reduction, increased stage 1 and 2 detection and a favorable trend over time in each screening round on combined stage 3 and 4 reduction, could be compelling to these systems even though the primary endpoint was not met.
+Added: We believe the evidence package is even stronger when taken together with the positive results from our PATHFINDER 2 study.
Since our founding, we have undertaken a rigorous approach to identify in a blood sample the most informative markers of cancer through what we believe is the largest clinical program in genomic medicine to date.
−Removed: We are collecting population-scale clinical data from more than 385,000 participants across nine clinical studies, with more than 21,000 of these participants included in the studies that supported the development and
−Removed: launch of Galleri, and over 175,000 individuals enrolled and an additional approximately 50,000 anticipated to be enrolled in interventional studies (NHS-Galleri and PATHFINDER 2, which support our PMA submission, and the first-of-its kind Galleri-Medicare real-world study).
−Removed: These studies include our foundational case-control CCGA study to develop and validate our MCED technology, multiple large-scale observational studies in asymptomatic individuals, and multiple large-scale interventional studies in intended use populations.
−Removed: Our interventional studies include our NHS-Galleri Trial, which is the first and largest randomized controlled trial of an MCED test, and which enrolled more than 140,000 individuals in just over 10 months.
−Removed: These studies also include our initiation of the Real-world Evidence to Advance multi-Cancer early detection Health equity (“REACH” or “Galleri-Medicare”) interventional study.
−Removed: This first-of-its kind real-world Galleri-Medicare study will further evaluate the clinical impact of the Galleri multi-cancer early detection test among Medicare beneficiaries, including racial and ethnic minorities, and seniors from historically underserved communities.
+Added: We are collecting population-scale clinical data from more than 385,000 participants across nine clinical studies, including over 180,000 patients enrolled in our PATHFINDER and PATHFINDER 2 clinical studies and our NHS-Galleri Trial, the only interventional trials conducted in an intended use population to validate an MCED test.
+Added: We are also enrolling up to 50,000 Medicare beneficiaries in our Real-world Evidence to Advance multi-Cancer early detection Health equity (“REACH” or “Galleri-Medicare”) interventional study designed to evaluate the clinical impact of Galleri in a population of Medicare beneficiaries, including racial and ethnic minorities, and seniors from historically underserved communities.
+Added: These studies also include our foundational case-control CCGA study and interventional PATHFINDER study, which were used to develop and validate our MCED technology and launch Galleri as a commercial laboratory developed test (“LDT”) product.
Through these studies and our ongoing collection of real-world data, we have built what we believe is an unprecedented longitudinal dataset of high quality, linked clinical and genomic data.
+Added: We believe that a number of findings in the NHS-Galleri Trial, together with the positive PATHFINDER 2 results, provide strong evidence of the clinical utility of Galleri in a population.
+Added: The NHS-Galleri Trial is a rigorous, randomized control trial of over 140,000 participants that we designed in dialogue with the NHS.
+Added: The main goal of the trial was to establish whether Galleri could provide a meaningful contribution towards achieving the NHS’s ambitious goal to achieve a significant shift in late stage cancer diagnosis by 2028.
+Added: The endpoint of a reduction in stage 3-4 cancers combined was chosen as the primary endpoint because, at the time, it was most closely aligned with the NHS Long Term Plan, which was the basis for designing a broader implementation pilot within the NHS.
+Added: We believe that the trial’s most important secondary endpoint, stage 4 reduction, also works toward this goal.
+Added: Although the primary endpoint of statistically significant combined stage 3 and 4 reduction was not observed in the NHS-Galleri Trial, we believe the results of the trial provide evidence that Galleri can contribute to this goal.
+Added: This goal is supported by the favorable trend shown toward fewer stage 3 and 4 cancers in the intervention arm after the prevalent screening round in the pre-specified group of 12 deadly cancers.
+Added: Importantly, we also saw substantial and clinically meaningful reduction in stage 4 cancer, with more than 20% reductions in the second and third screening round.
+Added: Had the stage 4 reduction endpoint been the primary endpoint, it would have been met.
+Added: The trial also showed a substantial reduction in the number of cancers detected clinically through emergency presentation, which are associated with significantly higher mortality and healthcare costs, and a substantial increase in stage 1 and 2 cancers detected.
+Added: In the trial, four times as many cancers were detected through Galleri combined with recommended screening compared to recommended screening alone, which adds proof to a similar seven fold increase shown in PATHFINDER 2.
+Added: Taken together, we believe these strong results can provide a compelling evidence package to payers and other stakeholders, despite the trial not reaching the primary endpoint.
+Added: The clinical utility of Galleri is enabled by the strong underlying performance of the test.
We believe our clinical studies, including our early discovery work, have demonstrated robust and reproducible test performance.
−Removed: Notably, data from our interventional PATHFINDER study, including positive predictive value (“PPV”), cancer signal original prediction accuracy, and specificity, were generally consistent with data from our case-control CCGA study, which is evidence supporting the generalizability and robustness of Galleri in an interventional study involving analysis of returned Galleri results on clinical diagnostic and care pathways, outside of the foundational case-control context.
−Removed: Specifically, the 43% PPV achieved in the study is similar to our previously published modeled PPV of 44% based on test performance in our CCGA study extrapolated to a potential representative population aged 50-79 based on 2016 to 2017 SEER data.
+Added: Notably, the PATHFINDER 2 Initial Results presented at ESMO in October 2025 showed a PPV of 61.6%, substantially higher than our case-control CCGA study, and CSO accuracy of 92% and false positive rate of 0.4%, each consistent with the CCGA study.
+Added: In 2025, we also announced topline NHS-Galleri Prevalent Round Results, which also showed a substantially higher PPV than our CCGA study.
+Added: We believe the replication or improvement of the results from our case-control CCGA study in interventional studies in an intended use population is evidence supporting the generalizability and robustness of Galleri and the potential usefulness of returned Galleri results in clinical diagnostic and care pathways.
+Added: Our previously published modeled PPV of 44% was based on test performance in our CCGA study extrapolated to a potential representative population aged 50-79 based on 2016 to 2017 SEER data.
We extrapolated the CCGA-based modeled PPV to a representative population due to the limitations of measuring PPV in a case controlled study with enrichment of cancer cases in the sample set, whereas the PATHFINDER 2 study was performed in an intended use population and PPV was measured directly.
−Removed: Data from our foundational CCGA study was presented in oral and poster presentations at multiple major medical conferences including the American Association for Cancer Research (AACR), American Society of Clinical Oncology (ASCO) and European Society of Medical Oncology (ESMO) and were published in Annals of Oncology in 2020 and 2021 and Cancer Cell in 2022.
−Removed: Data from our PATHFINDER study was initially presented at the ESMO in 2021 and published in The Lancet in 2023.
−Removed: Additional data on patient reported outcomes was published in Lancet Oncology in January 2025.
+Added: Data from our foundational CCGA study was presented in oral and poster presentations at multiple major medical conferences including the AACR, ASCO and ESMO and were published in Annals of Oncology in 2020 and 2021 and Cancer Cell in 2022.
+Added: Results from our first PATHFINDER study presented at ASCO in 2021, analyzing data from 6,629 individuals aged 50 years or older, showed a PPV consistent with CCGA.
+Added: Results from the full approximately 35,000 participants in the PATHFINDER 2 study were generally consistent with the results presented at ESMO.
+Added: Galleri test performance in the NHS-Galleri Trial was consistent with the range previously reported from our North American studies.
We expect to continue to report clinical data from our clinical program over many years.
−Removed: Based on our extensive, published and peer reviewed discovery work, we believe that a targeted methylation approach, which entails interrogating specific methylation sites within a genome to assess methylation patterns and which is an integral part of the technology used in our Galleri test, is the best approach for detecting a cancer signal and identifying a cancer signal origin.
−Removed: In our head-to-head analyses we compared multiple different classifiers that were trained to detect a cancer signal and predict the cancer signal origin, and which were independently validated.
−Removed: We found that interrogating methylation patterns yielded significantly better results for cancer detection (based on sensitivity, cancer signal origin prediction accuracy, and clinical limit of detection (a measure of the how much signal must exist in order to be detected)) than was observed by interrogating mutations (changes in a DNA sequence), chromosomal alterations (changes to the structure or number of chromosomes, which are strands of genetic material), fragment lengths (differences in length of DNA fragments), and other genomic features, either alone or in combination.
+Added: We have also gained insight from studies of the use of our methylation technology in other populations and in the real world.
+Added: Our SYMPLIFY study, a prospective multi-center observational study, represents the first large-scale evaluation of an MCED test in symptomatic patients who were referred from the primary care setting due to clinical suspicion of cancer.
+Added: This patient population represents a distinct patient population from the asymptomatic screening population assessed in the PATHFINDER and PATHFINDER 2 studies and the NHS-Galleri Trial.
+Added: Initial analysis from the study after nine month follow up showed strong PPV and consistent CSO.
+Added: But in an analysis based on continued follow up through 24 months through national cancer registries, we found that 35.4% (28 of 79) of patients initially determined to be false positives were diagnosed with cancer.
+Added: This reduction in false positives by approximately one third resulted in an updated PPV of 84.2%, and 27 of these 28 participants had a correct CSO prediction.
+Added: Real world evidence, while not directly comparable to our clinical study evidence, is also an important part of our program, with publications and presentations by us and our partners showing Galleri performance in the clinic and building best practices for implementation and follow up that can be used in key health systems.
+Added: Based on our extensive, published and peer reviewed discovery work, we believe that a targeted methylation approach, which entails interrogating specific methylation sites within a genome to assess methylation patterns and which is an integral part of the technology used in our Galleri test, is the best approach for detecting a cancer signal and identifying a CSO.
+Added: In our head-to-head analyses we compared multiple different classifiers that were trained to detect a cancer signal and predict the CSO, and which were independently validated.
+Added: We found that interrogating methylation patterns yielded significantly better results for cancer detection (based on sensitivity, CSO prediction accuracy, and clinical limit of detection (a measure of the how much signal must exist in order to be detected)) than was observed by interrogating mutations (changes in a DNA sequence), chromosomal alterations (changes to the structure or number of chromosomes, which are strands of genetic material), fragment lengths (differences in length of DNA fragments), and other genomic features, either alone or in combination.
In contrast to well-established cancer mutations that only affect a handful of genomic locations, there are nearly 30 million methylation sites across the human genome, making them a ubiquitous and rich signal for cancer detection.
−Removed: After comprehensive analysis of whole-genome methylation patterns in connection with our CCGA study, we discovered highly informative and low-noise methylation sites for cancer signal and cancer signal origin detection.
+Added: After comprehensive analysis of whole-genome methylation patterns in connection with our CCGA study, we discovered highly informative and low-noise methylation sites for cancer signal and CSO detection.
Highly informative sites are likely to have abnormal methylation patterns resulting from cancer, and low-noise sites are less likely to be subject to confounding signals from biological noise resulting from confounding conditions (such as aging, inflammatory conditions) and circulating DNA from non-cancerous cells.
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Our targeted methylation approach can detect lower levels of cancer signal in blood compared to the other approaches we examined, enabling early cancer detection in asymptomatic individuals more efficiently compared to whole-genome methylation.
−Removed: Our targeted methylation assay had a clinical limit of detection of approximately 150 parts per million, which was significantly lower than other approaches we assessed.
+Added: Our targeted methylation
+Added: assay had a clinical limit of detection of approximately 150 parts per million, which was significantly lower than other approaches we assessed.
Our proprietary targeted methylation platform, as well as our growing body of clinical and real-world data, have provided us with unique insights into cancer biology that enable development of products beyond asymptomatic screening.
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From a simple blood draw, Galleri can detect a cancer signal shared by over 50 types of cancer, over 45 of which do not have recommended screening guidelines.
−Removed: We believe Galleri enables the early detection of cancer in asymptomatic individuals by screening for multiple types of cancer, and in clinical studies has demonstrated a high positive predictive value (“PPV”) and a low false positive rate, and an ability to predict the location of the suspected cancer with high accuracy.
+Added: Galleri has shown strong clinical utility in the NHS-Galleri Trial, showing substantial reduction in stage 4 cancer diagnoses, increased stage 1 and 2 detection of deadly cancers, and four-fold higher cancer detection rate when compared to recommended screenings alone.
+Added: Although the primary endpoint of statistically significant combined stage 3 and 4 reduction was not observed, there was a favorable trend toward fewer combined stage 3 and 4 cancers in a pre-specified group of 12 deadly cancers after the prevalent screening round Galleri achieves these clinical utility results through its strong performance characteristics in MCED screening for asymptomatic individuals, and has demonstrated an ability to accurately predict CSO, with high PPVs and low false positive rates.
Galleri screening test results can help guide next steps for a diagnosis of cancer by healthcare providers in required follow-up diagnostic testing.
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We launched Galleri in the United States in mid-2021.
−Removed: As of December 31, 2024, we have sold more than 290,000 commercial tests and established commercial partnerships, including leading healthcare systems, employers, payors, and life insurance providers.
+Added: As of December 31, 2025, we have sold more than 475,000 commercial tests, including more than 185,000 tests in 2025, and have established commercial partnerships, including leading healthcare systems, employers, digital health platforms, payors, and life insurance providers.
In late 2024, we began use of a new version of Galleri in commercial channels which incorporates significant automation and is intended to enable us to scale more efficiently with future demand.
−Removed: Our clinical trials continue to use the same version of Galleri as when they were started, and we expect to conduct any necessary bridging studies from later versions of Galleri in connection with FDA or other regulatory approval.
In this real-world setting, Galleri is detecting deadly cancers in early stages, and healthcare providers have self-reported to us that Galleri’s signal origin capability enables them to efficiently direct the pathway following a positive test.
−Removed: As an early proponent of MCED testing, we have established strong relationships within the cancer and primary care community, including through partnerships with academic and
−Removed: community medical centers, key opinion leaders, and governmental policy and advocacy partners.
−Removed: Our partnership with the NHS presents an opportunity to drive further adoption of Galleri, including by payors and health systems around the world.
−Removed: The NHS will evaluate the final results from the NHS-Galleri Trial, which are expected to be available in 2026, before determining whether to implement the Galleri test in the NHS.
−Removed: We believe the decision will include considerations such as NHS budget, political priorities, cost-effectiveness and implementation constraints in addition to an evaluation of the final results.
+Added: As an early proponent of MCED testing, we have established strong relationships within the cancer and primary care community, including through partnerships with academic and community medical centers, key opinion leaders, and governmental policy and advocacy partners.
+Added: Our dialogue with the NHS presents an opportunity to drive further adoption of Galleri, including by payors and health systems around the world.
+Added: The NHS will evaluate the final results from the NHS-Galleri Trial, alongside other factors, before determining whether to implement the Galleri test in the NHS.
+Added: We have also begun entering select international markets through distributor partners, including Israel and Canada, and intend to enter South Korea through our partnership with Samsung.
Our commercial leadership is further supported by our high-capacity laboratory which is equipped to process Galleri tests at population screening volumes.
• Unprecedented clinical studies and real-world experience.
−Removed: We designed and executed what we believe is the largest clinical program in genomic medicine to date.
−Removed: We are collecting population-scale clinical data from more than 385,000 participants across nine clinical studies, with more than 21,000 of these participants included in the studies that supported the development and launch of Galleri, and over 175,000 individuals enrolled and an additional approximately 55,000 anticipated to be enrolled in interventional studies (NHS-Galleri and PATHFINDER 2, which support our PMA submission, and the first-of-its kind Galleri-Medicare real-world study).
−Removed: These studies include our foundational case-control CCGA study to develop and validate our MCED technology, multiple large-scale observational studies in asymptomatic individuals, and multiple large-scale interventional studies.
−Removed: Our interventional studies include our NHS-Galleri Trial, which is the first and largest randomized controlled trial of an MCED test, and which enrolled more than 140,000 individuals in just over 10 months.
+Added: We designed and executed what we believe is th e largest clinical program in genomic medicine to date.
+Added: We have deep operational experience with over 800,000 tests processed across this clinical program and from our commercial experience, including through partnerships with leading healthcare systems, employers, di gital health platforms, payors, and life insurance providers.
+Added: We are collecting population-scale clinical data from more than 385,000 participants across nine clinical studies, including over 180,000 patients enrolled in our PATHFINDER and PATHFINDER 2 clinical studies and our NHS- Galleri Trial, the only interventional trials conducted in an intended use population to validate an MCED test.
+Added: Our NHS-Galleri Trial, the first and largest randomized controlled trial of an MCED test, enrolled more than 140,000 individuals in just over 10 months.
+Added: We are also enrolling up to 50,000 Medicare beneficiaries in our REACH/Galleri-Medicare study designed to evaluate the clinical impact of the Galleri MCED test among Medicare beneficiaries, including racial and ethnic minorities, and seniors from historically underserved communities.
Through these studies and our ongoing collection of real-world data, we have built what we believe is an unprecedented longitudinal dataset of high quality, linked clinical and genomic data.
−Removed: We believe our clinical studies, including our early discovery work, have demonstrated robust and reproducible test performance.
−Removed: Notably, data, including PPV, cancer signal original prediction accuracy, and specificity, from our interventional PATHFINDER study, which involved analysis of diagnostic and care pathways outside of the case-control context, were generally consistent with data from our case-control CCGA study, which is evidence supporting the consistent performance of Galleri.
−Removed: Together with our partners at leading community and academic medical centers in the United States and United Kingdom, we expect to continue to report ongoing and long-term follow-up clinical data from our studies over many years.
+Added: We believe our clinical studies, including our early discovery work, have demonstrated robust and reproducible test performance as evidenced in the consistency in performance - including PPV, CSO accuracy and false positive rate - between our foundational work in CCGA and large scale study results from the NHS-Galleri Trial and PATHFINDER 2.
+Added: We have submitted data from the NHS-Galleri Prevalent Screening Round and the PATHFINDER 2 Initial Results to the FDA as part of our PMA package.
+Added: Together with our partners at leading community and academic medical centers in the United States and the United Kingdom, we expect to continue to report ongoing and long-term follow-up clinical data from our studies over many years.
• Our highly-differentiated methylation platform, which enables product opportunities across the cancer care continuum.
We have taken a scientifically rigorous approach to develop a deep and comprehensive understanding of cancer biology.
−Removed: We built an atlas to characterize the landscape of cell-free nucleic acids (“cfDNA”) across a broad and diverse population and in individuals with and without cancer.
−Removed: We then used this atlas and other data to train our machine learning algorithms to recognize methylation patterns indicative of cancer and accurately predict the cancer signal origin.
−Removed: These efforts supported the development of our proprietary methylation platform on which Galleri is based, and which we will continue to leverage to advance a number of clinical applications across the cancer care continuum.
+Added: Our first version of Galleri was built from an atlas that characterized the landscape of cell-free nucleic acids (“cfDNA”) across a broad and diverse population and in individuals with and without cancer.
+Added: We then used this atlas and other data to train our machine learning algorithms to recognize methylation patterns indicative of cancer and accurately predict the CSO.
+Added: We have continued to use data from our clinical studies to refine Galleri, designing for improved performance and cost efficiency over time.
+Added: We have also used our proprietary methylation platform, on which Galleri is based, to advance a number of clinical applications across the cancer care continuum.
For example, we developed and launched our post-diagnosis RUO offering and are working closely with biopharmaceutical companies to develop products and services to optimize treatment once a cancer has been diagnosed.
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Specifically, as of December 31, 2025, we have exclusive licenses to approximately 408 granted patents globally, and own or co-own more than 221 issued patents, with more than 400 pending patent applications (licensed, owned, or co-owned) covering methylation and other technologies.
−Removed: In addition, our patents, trade secrets, and know-how provide broad intellectual property coverage for our products, including chemistry, bioinformatics, and machine learning algorithms used in
−Removed: Galleri and our product development pipeline.
+Added: In addition, our patents, trade secrets, and know-how provide broad intellectual property coverage for our products, including chemistry, bioinformatics, and machine learning algorithms used in Galleri and our product development pipeline.
Our exclusively licensed patents will begin to expire in 2027.
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The commercial opportunity for Galleri is significant, with more than 300 million individuals in major global markets over the age of 50, including over 100 million individuals in the United States.
−Removed: Our goal is to address cancer screening globally, beginning in large markets with established health systems, such as the United States and United Kingdom, and extending to other markets over time through both direct market entry and distributors.
+Added: Our goal is to address cancer screening globally, beginning in large markets with established health systems, such as the United States and the United Kingdom, and extending to other markets over time through both direct market entry and distributors.
We will continue to engage with key opinion leaders, healthcare providers, advocacy organizations, regulators, and payors to help drive broader scientific and commercial endorsement worldwide.
−Removed: In addition, we believe Galleri’s performance will drive clinical outcomes and high patient and provider satisfaction that will lead to further awareness and adoption.
+Added: In addition, we believe Galleri’s performance and Galleri’s utility in clinical practice, as demonstrated in our NHS-Galleri Trial (although it did not reach its primary endpoint) and PATHFINDER 2 studies, will drive clinical outcomes and high patient and provider satisfaction that will lead to further awareness and adoption.
+Added: In particular, we have conducted market research showing that a stage 4 shift like that shown in the NHS-Galleri Trial would significantly influence a provider’s willingness to prescribe.
• Expanding access to our products by pursuing FDA approval and reimbursement and coverage from payors.
Our ability to impact cancer outcomes will be accelerated in markets where we secure reimbursement for our products.
−Removed: Prior to broader coverage and reimbursement in the United States, we will continue our work with clinics and health systems to accelerate utilization, and with self-insured employers and health insurers to offer and cover Galleri.
−Removed: In the United States, we have established private reimbursement from a number of self-insured employers and multiple payors and health systems as of December 31, 2024, but do not currently have broad coverage and reimbursement by government healthcare programs, such as Medicare.
−Removed: We plan to pursue FDA approval to help support broad access for Galleri in the United States.
−Removed: We plan to complete a PMA submission with the FDA in the first half of 2026.
−Removed: We seek to use data from the NHS-Galleri Trial, together with data from our PATHFINDER 2 study, as well as supplemental data from other clinical studies, to support our planned PMA submission for Galleri in the United States.
−Removed: We believe that FDA approval could unlock large commercial payors in the United States and we are working with stakeholders to advance and shape the public reimbursement landscape in the United States to enable coverage of FDA-approved MCED tests by Medicare.
−Removed: Galleri has not been approved or cleared by the FDA and obtaining PMA approval can take several years, if at all, from the time a premarket application is submitted.
−Removed: Moreover, the FDA requirements that will govern MCED tests, as well as the breadth and nature of data we must provide the FDA to support the proposed intended use, may be subject to change, and as such it is difficult to predict what information we will need to submit to obtain approval of a PMA from the FDA for a proposed intended use.
−Removed: Following FDA approval, we also expect to pursue inclusion of Galleri in the USPSTF’s guideline recommendation, although such inclusion is not certain even with FDA approval.
−Removed: In the United Kingdom, we are working with NHS England to complete our NHS-Galleri Trial.
−Removed: The NHS will evaluate the final results from the NHS-Galleri Trial, which are expected to be available in 2026, alongside other factors, before determining whether to implement the Galleri test in the NHS.
−Removed: We believe our work with the NHS and the data generated from our NHS-Galleri Trial, if favorable, could help facilitate adoption in other single-
−Removed: payor systems around the world and support evidence of clinical utility worldwide.
+Added: Prior to broader coverage and reimbursement in the United States, we will continue our work with clinics, health systems and digital health platforms to accelerate utilization, and with self-insured employers and health insurers to offer and cover Galleri.
+Added: In the United States, as of December 31, 2025 we have established coverage and reimbursement from a number of self-insured employers and multiple payors and health systems, including certain government payors such as TRICARE, but do not currently have broad coverage and reimbursement by government healthcare programs, such as Medicare, or large commercial payors.
+Added: We are pursuing FDA approval to help support broad access for Galleri in the United States, and submitted our PMA to the FDA in January, 2026.
+Added: We believe that FDA approval could unlock large commercial payors in the United States.
+Added: In February 2026, a new law created a coverage benefit category to enable coverage of FDA-approved MCED tests by Medicare, with authority for CMS to initiate coverage as early as January 1, 2029 for the aged 50-65 Medicare population and expanding one age-year at a time annually.
+Added: Nonetheless, no version of Galleri has been approved or cleared by the FDA and obtaining PMA approval can take several years, if at all, from the time the premarket application was submitted.
+Added: Galleri may not be approved on our expected timeline or at all.
+Added: If FDA approval is obtained, we also expect to pursue inclusion of Galleri in the USPSTF’s guideline recommendation, although such inclusion is not certain even with FDA approval.
+Added: In the United Kingdom, we are in dialogue with NHS England.
+Added: The NHS will evaluate the final results from the NHS-Galleri Trial, alongside other factors, before determining whether to implement the Galleri test in the NHS.
+Added: We believe our work with the NHS and the data generated from our NHS-Galleri Trial (although it did not reach its primary endpoint), could help facilitate adoption in other single-payor systems around the world and support evidence of clinical utility worldwide.
We will continue to invest in clinical evidence generation and work with regulatory bodies and payors in our target markets to expand coverage for early cancer screening and to increase access.
• Defining, leading, and expanding adoption of MCED.
−Removed: We coined the term “multi-cancer early detection” and will continue to drive MCED as a solution to one of healthcare’s most important challenges.
+Added: We pioneered the field of multi-cancer early detection and will continue to drive MCED as a solution to one of healthcare’s most important challenges.
Since our inception in 2016, we have established and maintained a leading voice regarding the early detection of multiple cancer types in peer-reviewed literature.
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We fund medical education programs for MCED and intend to continue to educate healthcare providers, as well as key opinion leaders, regulators, professional societies, and policymakers on the clinical benefits and public health impact of MCED.
−Removed: In addition, we believe this market development strategy will drive adoption of our products and further awareness of the benefits of MCED testing generally.
+Added: We believe this market development strategy will drive adoption of our products and further awareness of the benefits of MCED testing generally.
• Leveraging our existing infrastructure to enable and scale our growing business.
−Removed: Over the last several years, we have made significant investments to build a scalable infrastructure capable of meeting significant demand while satisfying stringent certification parameters.
−Removed: Our high-capacity laboratory is accredited by the College of American Pathologists (“CAP”) and certified by the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”) and the New York State Department of Health, which represent one of the most rigorous levels of validation required for laboratory developed tests.
−Removed: With the roll-out of our new version of Galleri, our facility is able to process test volumes in excess of our current forecasts without requiring significant additional investment in capital expenditures.
+Added: Over the last several years, we have made significant investments to build a scalable infrastructure capable of meeting significant demand of up to one million tests per year while satisfying stringent certification parameters.
+Added: Our high-capacity laboratory is accredited by the College of American Pathologists (“CAP”) and certified by the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”) and the New York State Department of Health (“NYSDoH”), which represents one of the most rigorous levels of validation required for laboratory developed tests.
+Added: With the roll-out of our new version of Galleri in late 2024, our facility is able to process test volumes in excess of our current forecasts without requiring significant additional investment in capital expenditures.
In addition, we engineered custom technology infrastructure and cloud-based tools to enable scalable data collection and analysis capabilities.
−Removed: Our ability to collect, manage, and integrate high-quality genomic and clinical data is central to our business, and our automated laboratory workflows and processes enable high volumes of tests and samples to be processed automatically with high efficiency and speed and low failure rates.
+Added: Our ability to collect, manage, and integrate high-quality genomic and clinical data is central to our business, and our automated laboratory workflows and processes enable high volumes of tests and samples to be processed automatically with high efficiency, speed and low failure rates.
As demand for our products increases, we expect to leverage the scale efficiencies of our infrastructure and platform technology, which we believe will positively impact margins over time.
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Further, we plan to improve our products to enhance performance, offerings, scalability, and/or cost of goods.
−Removed: New products, including enhanced versions of current products, will require the completion of certain clinical development and regulatory activities, such as any required non-inferiority studies using data (for example, clinical data and/or real world evidence data obtained through Galleri’s commercial use) and/or bridging studies, which may be agreed upon with regulatory authorities.
+Added: New products, including enhanced versions of current products, require the completion of certain clinical development and regulatory activities, such as any required non-inferiority or bridging studies, which may draw on clinical or real world data obtained through Galleri’s commercial use and which may need to be agreed upon with regulatory authorities.
We will continue to improve our technologies and launch innovative products across the cancer care continuum.
• Sustaining a patient-first corporate culture that attracts top talent.
−Removed: We have built a multi-disciplinary organization of leading scientists, engineers, and clinicians with a variety of backgrounds, all driven to improve outcomes for cancer patients.
−Removed: In our pursuit to improve cancer
−Removed: care and solve one of healthcare’s most important challenges, we recognize the importance of a workforce with different experiences, and we will continue to foster an agile and inclusive environment that is a destination for world-class talent with expertise from a variety of backgrounds.
+Added: We have built a multi-disciplinary organization of leading scientists, engineers, clinicians and other professionals with a variety of backgrounds, all driven to improve outcomes for cancer patients.
+Added: In our pursuit to improve cancer care and solve one of healthcare’s most important challenges, we recognize the importance of a workforce with different experiences, and we will continue to foster an agile and inclusive environment that is a destination for world-class talent with expertise from a variety of backgrounds.
We believe our mission, values, and leadership attributes all contribute to this vibrant and inclusive culture and serve as a powerful magnet for talent.
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The Burden of Cancer and the Benefits of Earlier Detection
−Removed: Cancer is the second leading cause of death in both the United States and worldwide, with more than 19 million new cases and 10 million deaths globally in 2020.
+Added: Cancer is a leading cause of death in both the United States and worldwide, with more than 20 million new cases and 10 million deaths globally in 2022.
This burden is expected to grow as the global population ages.
−Removed: According to the data in the American Cancer Society’s Cancer Facts & Figures 2025 , there will be approximately 2.0 million new cancer cases and 618,000 cancer deaths in the United States in 2025.
+Added: According to the data in the American Cancer Society’s Cancer Facts & Figures 2026 , there are expected to be 2.1 million new cancer cases and 626,000 cancer deaths in the United States in 2026.
An analysis published in the AACR’s Cancer Epidemiology, Biomarkers and Prevention Journal (Cancer Epidemiol Biomarkers Prev.
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2(30):2–16) estimated that diagnosing cancer early could result in $26 billion (approximately 17% of total treatment costs) in annual cancer treatment cost-savings in the United States.
+Added: MCED screening also has the potential to detect more cancers without emergency department involvement, which is associated with twice the mortality rate and over $100,000 higher health care costs in the first year, even when adjusted for cancer stage.
Our Multi-Cancer Early Detection Test:
Our commercially available multi-cancer early detection screening test, Galleri, is transforming cancer care and has the potential to unlock substantial improvements in cancer detection and mortality.
−Removed: A fundamental driver of cancer mortality today is that most cancers that result in death are diagnosed too late, in advanced stages when they are most challenging to treat.
−Removed: If cancer is detected early, when it is localized, it is more amenable to curative treatment.
Galleri is designed to complement the USPSTF’s recommended screenings, be easy to implement in practice, and improve overall population cancer detection.
−Removed: From a simple
−Removed: blood draw, Galleri can detect a cancer signal shared by over 50 types of cancer, over 45 of which do not have recommended screening guidelines.
−Removed: We believe Galleri enables the early detection of cancer in asymptomatic individuals by screening for multiple types of cancer, and in clinical studies Galleri has demonstrated an ability to predict the location of the suspected cancer with high accuracy (88%), and high PPVs and low false positive rates.
+Added: From a simple blood draw, Galleri screens an individual for a cancer signal shared by over 50 types of cancer, over 45 of which do not have recommended screening guidelines.
+Added: Galleri has been studied in large clinical trials, including over 180,000 participants enrolled in interventional trials in the intended use population.
+Added: In these clinical studies, Galleri has demonstrated an ability to predict the location of the suspected cancer with high accuracy, high PPV and a low false positive rate.
For additional information, see “Business—Our Clinical Studies.” Galleri screening test results can help guide next steps for a diagnosis of cancer by healthcare providers in required follow-up diagnostic testing.
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As of December 31, 2025, we have sold more than 475,000 commercial tests.
−Removed: In this real-world setting, Galleri has detected deadly cancers in early stages.
−Removed: Our test has been deployed across healthcare systems, employers, payors, and life insurance providers, and for additional at-risk groups such as first responders, including firefighters, and continues to unlock the promise of early cancer detection.
+Added: In this real-world setting, Galleri has detected deadly cancers in early stages, including, among others, endometrial, esophageal, gastrointestinal, head and neck, liver, pancreatic, and rectal cancers.
+Added: Our test has been deployed across healthcare systems, employers, digital health platforms, payors, and life insurance providers, and for additional at-risk groups such as first responders, and continues to unlock the promise of early cancer detection.
We developed Galleri with the following critical features necessary to address the requirements of a population-scale MCED screening test:
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We believe that Galleri can significantly increase the number of cancer types screened for in the population and has the potential to increase yield of cancers in the United States that are diagnosed through screening from 14% to 49%.
+Added: This is supported by our PATHFINDER 2 Initial Results, where adding Galleri to recommended screenings led to a more than seven-fold increase in the number of cancers found within a year, and an approximately three-fold increase when prostate screening was included.
+Added: Similarly we saw a four-fold increase in the number of cancers found in our NHS-Galleri Trial.
+Added: Approximately three-quarters of the cancers detected by Galleri do not have standard of care screening options.
High PPV and low false positive rate
−Removed: In clinical studies, Galleri has demonstrated a high PPV of approximately 43% and a low false positive rate of less than 1%.
+Added: In the PATHFINDER 2 Initial Results, Galleri demonstrated a high PPV of 61.6% and a low false positive rate of only 0.4%.
+Added: Results from the full approximately 35,000 participants in the PATHFINDER 2 study were generally consistent with the PATHFINDER 2 Initial Results and performance from our NHS-Galleri Trial was consistent with the range previously reported from our North American studies.
A high PPV, which is enabled in part by a low false positive rate, is important in clinical practice because it represents the probability that a positive test result is a true positive and can give clinicians high confidence and a sense of urgency to initiate confirmatory diagnostic workups.
A low false positive rate can help to limit unnecessary workups on patients who do not have cancer.
−Removed: While Galleri is designed to complement the current standard of care screening tests, Galleri’s high PPV of approximately 43% is significantly higher than the PPV of all of the standard of care single-cancer screening tests.
+Added: While Galleri is designed to complement the current standard of care screening tests, Galleri’s high PPV is significantly higher than the PPV of all of the standard of care single-cancer screening tests.
Galleri’s low false positive rate of less than 1% is also significantly lower than the false positive rate of all of the standard of care single-cancer screening tests.
−Removed: Ability to predict with high accuracy the cancer signal origin and direct diagnostic workup
−Removed: In our PATHFINDER study, Galleri demonstrated a high (88%) cancer signal origin prediction accuracy for identifying the location of cancer, which supports physician approaches to diagnostic resolution through well-established workup pathways.
−Removed: Cancer signal origin prediction accuracy represents the extent to which first and second origins identified were correct among true positive tests.
−Removed: In our PATHFINDER study, the first workup based on cancer signal origin facilitated a diagnostic resolution in 25 of the 32 participants who had diagnostic resolution (approximately 80%).
−Removed: Importantly, this group of 32 participants consisted of only those who received a cancer signal detected result from both Galleri and an earlier version of our MCED test also being studied in our PATHFINDER study.
−Removed: We also found that Galleri’s cancer signal origin prediction generally facilitated diagnosis in less than three months (median of 79 days) among participants who had a cancer signal detected.
−Removed: Further, Galleri’s cancer signal origin prediction capability enables physicians to limit the use of full body imaging following cancer signal detected results, which can be expensive, not readily accessible to broad patient populations, exposes patients to radiation, and can lead to false alarms and unnecessary ancillary workups.
+Added: The PPV reported in PATHFINDER 2 for Galleri is based on whether cancer could be confirmed or other diagnostic resolution reached within 12 months after the blood draw, given that the true cancer status of participants was not known at the time of blood draw.
+Added: Importantly, in our SYMPLIFY study in a symptomatic population, which is a different population than the asymptomatic population studied in PATHFINDER 2, PPV improved when the follow up window was extended from nine to 24 months, with 35.4% (28 of 79) of patients initially believed to have a false positive result later diagnosed with cancer.
+Added: Ability to predict with high accuracy the CSO and direct diagnostic workup
+Added: In the PATHFINDER 2 Initial Results, Galleri demonstrated a high CSO accuracy of 92% for identifying the location of cancer, which supports physician approaches to diagnostic resolution through well-established workup pathways.
+Added: Results from the full approximately 35,000 participants in the PATHFINDER 2 study showed a generally consistent CSO accuracy and CSO accuracy from our NHS-Galleri Trial was consistent with the range previously reported from our North American studies.
+Added: CSO prediction accuracy represents the extent to which the CSO identified were correct among true positive tests.
+Added: In the PATHFINDER 2 Initial Results, we found that Galleri’s CSO prediction facilitated diagnostic resolution in a median of 46 days, with only 0.6% of all participants undergoing an invasive procedure (159 of 25,114).
+Added: Invasive procedures were two times more common in participants with cancer than in those without.
+Added: Further, Galleri’s CSO prediction capability enables physicians to limit the use of full body imaging following cancer signal detected results, which can be expensive, not readily accessible to broad patient populations, expose patients to radiation, and can lead to false alarms and unnecessary ancillary workups.
In the commercial setting healthcare providers have self-reported to us that Galleri’s signal origin capability enables them to efficiently direct the pathway following a positive test.
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Galleri screening test performance is validated by extensive clinical studies.
−Removed: We have established a broad population-scale clinical evidence program, including the more than 21,000 participants included in the studies that supported the development and launch of Galleri.
−Removed: We believe we established clinical validation using a locked assay and classifier in case-control and intended-use populations.
−Removed: A locked assay means that the assay and classifier are fully specified, with no further adjustments.
−Removed: A locked assay and classifier produce the same result,
−Removed: within process control limits, when the same input is applied.
+Added: We have established a broad population-scale clinical evidence program, including approximately 35,000 participants in our PATHFINDER 2 interventional study in our intended use population and over 140,000 participants in our NHS-Galleri Trial measuring clinical utility, and more than 21,000 participants included in the studies that supported the development and initial launch of Galleri.
+Added: We initially locked our assay for our commercial launch and have made periodic planned updates with additional locks, such as our implementation of our highly automated laboratory process and for our PMA submission.
+Added: We believe we have established clinical validation on the locked versions of our assay and classifier in case-control and intended-use populations.
+Added: A locked assay means that the assay and classifier are fully specified, with no further adjustments, other than planned updates.
+Added: Each version update to our assay and classifier involves a concordance or non-inferiority study to show similar performance to our prior version.
+Added: A locked assay and classifier produce the same result, within process control limits, when the same input is applied.
A case-control study is a type of observational study that interrogates factors associated with diseases or outcomes.
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Our CCGA study is an example of a case-control study, in that it enrolled participants with a cancer diagnosis (cases) and participants without a cancer diagnosis (controls).
−Removed: Importantly, study design and product development processes were robust enough to enable translation of similar performance from our foundational case control CCGA study to our interventional PATHFINDER study without seeing a degradation of performance.
+Added: Importantly, study design and product development processes were robust enough to enable translation of similar performance from our foundational case control CCGA study to our interventional PATHFINDER study without seeing a degradation of performance, and showing improved performance on some metrics in our PATHFINDER 2 and NHS-Galleri Trial.
We have shared evidence supporting Galleri’s performance at renowned medical conferences and published results from our studies in leading scientific and medical journals.
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Data across our clinical studies suggests that although Galleri detects cancer signals for some of the most aggressive cancers, detection of cancer signals for indolent cancer types, which people are less likely to die from, is low.
−Removed: For example, data published in JCO Precision Oncology in 2024 demonstrated that prostate cancers that were detected by Galleri were more aggressive and clinically significant as compared to indolent and slow growing cancers.
+Added: For example, data published in JCO Precision Oncology in 2024 demonstrated that prostate cancers that were detected by Galleri were more aggressive and clinically significant as compared to indolent and slow growing prostate cancers.
We believe these results demonstrate that the use of MCED tests in a population-based screening program is unlikely to contribute to overdiagnosis of slow-growing prostate cancers that may not need treatment.
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Additionally, we implemented multiple strategies to enroll a diverse and representative sample for our 140,000 participant NHS-Galleri study to enable trial results to be widely applicable.
+Added: We believe these validation studies in broad and diverse populations are essential for any MCED test to launch in a broad intended use population, such as adults over the age of 50.
Complementary to standard of care screenings
In the United States, the five standard of care single-cancer screening tests (breast, cervical, colorectal, lung cancer, and prostate) have helped to reduce mortality for these specific types of cancer.
−Removed: Galleri expands upon the current standard of care guidelines to screen individuals with a single test for many types of cancer, most of which have no recommended screenings.
+Added: Galleri expands upon the current standard of care guidelines to screen individuals with a single test for many types of cancer, over 70% of which have no recommended screenings.
We envision a world where Galleri is broadly accessible and used routinely alongside current standard of care screenings, potentially annually, to drive significant improvements in patient care and reduce cancer mortality and the cost of cancer care.
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30:460–8) that estimated the potential impact of MCED testing on mortality reduction based on test performance in our CCGA-2 study and using 2006 to 2015 SEER data for ages 50-79.
−Removed: Based on this model, we estimate that by adding Galleri to the five standard of care single-cancer screening tests (breast, cervical, colorectal, lung cancer, and prostate), there is potential to
−Removed: detect many more cancers at an earlier stage, which could translate into the potential to avert approximately 100,000 deaths per year in the United States as measured by five-year survival, or 39% of the five-year deaths expected if not for early detection by Galleri.
+Added: Based on this model, we estimate that by adding Galleri to the five standard of care single-cancer screening tests (breast, cervical, colorectal, lung cancer, and prostate), there is potential to detect many more cancers at an earlier stage, which could translate into the potential to avert approximately 100,000 deaths per year in the United States as measured by five-year survival, or 39% of the five-year deaths expected if not for early detection by Galleri.
We believe this model provides helpful context regarding the potential benefits of screening for multiple cancers at once with a singular screening test, like Galleri, in addition to the five standard of care single-cancer screening tests;
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Our model shows that the use of Galleri together with standard of care screenings could lead to the detection of three times as many cancer cases overall as compared to standard of care screenings alone, with only 6.5% more incremental false positives.
+Added: This modelling is supported by our PATHFINDER 2 study, where we found that adding Galleri to recommended screenings for breast, cervical, colorectal, and lung cancers (USPSTF A and B recommendations) led to a more than seven-fold increase in the number of cancers found within a year.
+Added: In that study, Galleri detected approximately three times as many cancers when added to standard-of-care screening for breast, cervical, colorectal, lung, and prostate cancers (USPSTF A, B, and C recommendations).
We estimate that identification of many more cancer cases with a limited number of additional false positives would reduce the cost to diagnose one cancer by approximately 65%.
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We believe ease of a blood draw can increase compliance by reducing some of the barriers that have limited the adoption of certain individual cancer screening tests, including the time to obtain the screening test as well as access to specialists and specialized equipment.
−Removed: In the commercial setting, healthcare providers have self-reported to us that Galleri’s cancer signal of origin capability enables them to efficiently direct the pathway following a positive test.
+Added: In the commercial setting, healthcare providers have self-reported to us that Galleri’s CSO capability enables them to efficiently direct the pathway following a positive test.
The test is available through a wide range of in-person and telemedicine care settings in the United States.
+Added: Importantly, in 2025 and early 2026 we have established partnerships with a number of digital health partners to bring Galleri to a broader audience of patients.
Galleri is conveniently accessible to patients who can complete the blood draw at physician offices, reference labs, and mobile phlebotomy labs, among other locations.
+Added: Key integrations, such as our integration with Quest to provide a simpler blood draw process and our planned integration with EPIC to simplify provider ordering, help make Galleri even more accessible.
In addition, Galleri can be easily integrated into routine practice, where healthcare providers can order Galleri as part of an annual examination.
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We offer patients a post-cancer signal detected result support center that provides materials they can bring to a referral to ensure the receiving physician understands the cancer signal detected test result to facilitate urgent care for such patients.
+Added: We also provide patient navigation services in the rare cases that patients require support in navigating post-positive care pathways.
In addition, our software systems support a positive experience for providers and their patients.
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We designed our software systems to integrate with third-party electronic medical record systems to streamline test ordering and results delivery.
−Removed: Importantly, for every test we process, we provide a clinically actionable test report, as depicted in the graphic below, that is delivered through our secure web portal to the ordering healthcare providers to show whether or not a cancer signal is detected, and if so, to predict where in the body the cancer signal is located.
−Removed: Through commercial and clinical use of Galleri, we’ve collected a number of positive patient testimonials from patients where Galleri detected a cancer signal, including from patients who have self-identified in media stories.
+Added: Importantly, for every test we process, we provide a clinically actionable test report, that is delivered through our secure web portal to the ordering healthcare providers and patient to show whether or not a cancer signal is detected, and if so, to predict where in the body the cancer signal is located.
+Added: Through commercial and clinical use of Galleri, we have collected a number of positive patient testimonials from patients where Galleri detected a cancer signal, including from patients who have self-identified in media stories.
Investment to Enhance Versions of Tests
We seek to continually enhance the performance and features of Galleri.
−Removed: Commercial use and ongoing research programs provide valuable data that we believe can enhance test performance.
+Added: Commercial use and ongoing research programs provide valuable data that we believe can enhance test performance, efficiency and other test characteristics.
Real-world evidence is already informing product improvements today.
+Added: In late 2024, we deployed an updated commercial version of our Galleri test incorporating an automated platform and in preparation for our PMA submission we developed and locked a new version for FDA review.
We will leverage even larger datasets to further develop our advanced machine learning algorithms.
−Removed: By further refining and selecting subsets of highly informative regions for cancer signal origin detection to reduce panel size, we could achieve deeper sequencing coverage and lower sequencing costs.
+Added: By further refining and selecting subsets of highly informative regions for CSO detection to reduce panel size, we could achieve deeper sequencing coverage and lower sequencing costs, as we did with our new version launched in 2024.
We also aim to further improve the sensitivity of our tests by obtaining deeper sequencing coverage and a better understanding of noise and leveraging even larger datasets to further develop our advanced machine learning algorithms.
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New products, including enhanced versions of current products, will require the completion of certain clinical development and regulatory activities, such as non-inferiority studies using clinical study data and real world evidence data obtained through Galleri’s commercial use and bridging studies to measure and evaluate concordance, performance and safety of a subsequent, enhanced version of our product versus the relevant existing product.
−Removed: Any bridging study may use previously collected clinical study data and other samples, and will need to be agreed upon with regulatory authorities.
+Added: Any bridging study will need to be agreed upon with regulatory authorities.
Precision Oncology Portfolio
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Partnerships may also include development of customized applications to support clinical studies and companion diagnostic development and commercialization.
−Removed: Our first companion diagnostic partnership was announced in 2022 with AstraZeneca and in 2024, we announced that the first patient has been tested for eligibility with the investigational GRAIL Non-Small Cell Lung Cancer (“NSCLC”) ctDNA Assay in AstraZeneca and Daiichi Sankyo’s global TROPION-Lung12 Phase 3 study evaluating adjuvant treatment regimens in patients with Stage I adenocarcinoma NSCLC.
+Added: Our first companion diagnostic partnership was announced in 2022 with AstraZeneca and AstraZeneca has selected Galleri for use in important trials.
+Added: Our RUO offering business is highly dependent on these partnerships and trials, and delays or terminations of trials can have a significant impact on the revenue we generate from this business, even if the reason for termination is unrelated to our RUO offering.
+Added: For example, in late 2025, one of our pharmaceutical partners terminated its phase 3 trial due to low enrollment, for which our methylation technology was used as a potential companion diagnostic for enrolling participants.
+Added: Even where trials are delayed or terminated, we may continue to have opportunities with the partner to continue developing companion diagnostics and other technology, or conduct other trials.
We have published or presented early performance data on MCED testing at multiple academic conferences, including ASCO, AACR and ESMO, across different use cases and indications.
3 unchanged sentences
Data from our studies have demonstrated analytically validated performance, and robust analytical sensitivity, specificity, and precision.
−Removed: For example, in a recent analytical validation study, cfDNA was analyzed from donors with and without cancer.
+Added: For example, we conducted an analytical validation study in which cfDNA was analyzed from donors with and without cancer.
Analytical sensitivity was assessed in 12 different solid tumor types.
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Our Clinical Studies
−Removed: We have built what we believe is one of the largest clinical programs in genomic medicine, which has generated what we believe is an unprecedented longitudinal dataset of high-quality, linked clinical and genomic data.
−Removed: We are collecting population-scale clinical data from more than 385,000 participants in numerous clinical studies, with more than 21,000 of these participants included in the studies that supported the development and launch of Galleri, and over 175,000 individuals enrolled and an additional approximately 50,000 anticipated to be enrolled in interventional studies (NHS-Galleri and PATHFINDER 2, which support our PMA submission, and the first-of-its kind Galleri-Medicare real-world study).
−Removed: The PATHFINDER 2 study and NHS-Galleri Trial are designed to support a PMA submission, with select inclusion criteria (matching the intended use population for Galleri), use of an appropriate assay (developed and commercially available), and enrollment of a sufficient number of participants to facilitate the generation of appropriate data and evidence.
−Removed: This design differs from our other studies, such as our CCGA study, which included participants outside of the intended use population for Galleri, and PATHFINDER study, which enrolled fewer participants and utilized an earlier version of Galleri for initial results.
−Removed: Additionally, we announced plans for a 100,000 individual real world study in the Medicare population, with a focus on racial and ethnic minorities and seniors aged 65 and above from under-served communities.
−Removed: The study seeks to compare up to 50,000 prospectively enrolled Medicare beneficiaries who have received usual care plus an annual Galleri test with a synthetic matched comparator arm of 50,000 beneficiaries who receive usual care alone, for up to three annual testing cycles.
−Removed: GRAIL is responsible for designing and executing this study and is planning to work with leading healthcare systems across the country and other key partners over the next few years.
−Removed: These foundational population-scale studies involve partnerships with numerous leading academic and cancer institutions and large community networks, including, among others, the Cleveland Clinic, Dana-Farber Cancer Institute, Guardian Research Network, Kettering Health, Mayo Clinic, Sutter Health, and the US Oncology Network.
−Removed: Our studies include the collection of blood and, as available and as directed by the protocol, tissue samples, demographic data, patient-reported outcomes data, and clinical data from participants.
−Removed: Clinical information, demographics, and medical data relevant to cancer status are collected from participants at time of enrollment and at regular intervals during a follow-up period.
−Removed: We integrate this information with the genomic data created from sequencing the samples and utilize these data to both train and validate our early cancer detection tests.
+Added: We have built what we believe is one of the largest clinical programs in genomic medicine to date.
+Added: Since our founding, we have undertaken a rigorous approach to identify in a blood sample the most informative markers of cancer.
+Added: We are collecting population-scale clinical data from more than 385,000 participants across nine clinical studies, including over 180,000 patients enrolled in our PATHFINDER and PATHFINDER 2 clinical studies and our NHS-Galleri Trial, the only interventional trials conducted in an intended use population to validate an MCED test.
+Added: We are also enrolling up to 50,000 Medicare beneficiaries in our Real-world Evidence to Advance multi-Cancer early detection Health equity (“REACH” or “Galleri-Medicare”) interventional study designed to evaluate the clinical impact of Galleri in a population of Medicare beneficiaries, including racial and ethnic minorities, and seniors from historically underserved communities.
+Added: These studies also include our foundational case-control CCGA study and interventional PATHFINDER study, which were used to develop and validate our MCED technology and launch Galleri as a commercial LDT product and other products.
+Added: Through these studies and our ongoing collection of real-world data, we have built what we believe is an unprecedented longitudinal dataset of high quality, linked clinical and genomic data.
+Added: The PATHFINDER 2 study and NHS-Galleri Trial were designed to support our PMA submission, with select inclusion criteria (matching the intended use population for Galleri), use of an appropriate locked assay, and enrollment of a sufficient number of participants to facilitate the generation of appropriate data and evidence to support safety and efficacy.
+Added: These foundational population-scale studies involve partnerships with numerous leading academic and cancer institutions and large community networks, including, among others, Cancer Hope Network, the Cleveland Clinic, Dana-Farber Cancer Institute, Geisinger Health, Guardian Research Network, HCA Healthcare, Memorial Sloan Kettering, Mayo Clinic, OcshnerHealth, Oregon Health Sciences University, Sutter Health, University of California San Francisco and the US Oncology Network.
+Added: Our studies include the collection of blood and, as available and as directed by the protocol, tissue samples, demographic data, patient-reported outcomes data, scan data and clinical data from participants.
+Added: We integrate this information with the genomic data created from sequencing the samples and utilize these data to both train and validate our tests.
Importantly, these are longitudinal studies and, in many cases, participant medical data will continue accruing for a number of years, facilitating analyses of longer-term outcomes, and further performance improvements of our products.
Our studies are conducted by various medical and oncology centers around the country.
+Added: Each of our studies has been conducted on an earlier version of Galleri than the currently available commercial version or the version we have submitted to the FDA for PMA approval.
+Added: Our clinical studies are summarized in the table below:
We were the first to invest in and initiate multiple, large clinical validation studies for multi-cancer early detection.
−Removed: Results from PATHFINDER, our first completed return-of-results study, provided critical data to support launch of Galleri and understand how clinicians implement Galleri into care pathways in clinical practice.
−Removed: We have completed enrollment in six additional studies:
−Removed: PATHFINDER 2, NHS-Galleri, Circulating Cell-free Genome Atlas (“CCGA”), SUMMIT, STRIVE, and SYMPLIFY.
−Removed: We are actively enrolling two studies:
−Removed: Galleri-Medicare (“REACH” or “Galleri-Medicare”) and REFLECTION.
−Removed: We have presented data and published results from our clinical studies in leading forums, including multiple major medical conferences, such as AACR, ASCO, and ESMO, and leading journals, such as The Lancet , Nature , Nature Medicine , Cancer Cell , and The Lancet Oncology .
−Removed: Data from our studies is expected to support regulatory filings as we pursue PMA approval.
−Removed: Importantly, our clinical program was designed to enable test development for population scale screening, and enrollment was managed to enable diversity across multiple characteristics including in behaviors (such as smoking), non-cancer diseases, environmental exposures, age, gender, race, ethnicity, socio-economic status, and other confounding indications and differences.
−Removed: Understanding and cataloging this diversity has enabled us to develop tests with high-specificity, cancer signal detection across many cancer types, and accurate cancer signal origin prediction.
−Removed: Long-term follow-up in the studies we have launched in years past will continue to yield critical data that we believe can help define the standard of care in early cancer detection.
+Added: Results from PATHFINDER, our first completed return-of-results study, provided critical data to support the launch of Galleri and understand how clinicians implement Galleri into care pathways in clinical practice.
+Added: Our PMA submission package includes the PATHFINDER 2 Initial Results, the NHS-Galleri Prevalent Round Results, and the Bridging Analysis.
+Added: We have completed enrollment in these studies:
+Added: NHS-Galleri, PATHFINDER 2, PATHFINDER, Circulating Cell-free Genome Atlas (“CCGA”), SUMMIT, STRIVE, and SYMPLIFY.
+Added: We are actively enrolling our REACH/Galleri-Medicare Study.
+Added: We are also conducting a real world evidence collection program called REFLECTION.
+Added: We have presented data and published results from many of these clinical studies in leading forums, including multiple major medical conferences, such as AACR, ASCO, and ESMO, and leading journals, such as The Lancet, Nature, Nature Medicine, Cancer Cell, and The Lancet Oncology.
+Added: Importantly, our clinical program was designed to enable test development for a diverse population, and enrollment was managed to capture diversity across multiple characteristics including diversity in behaviors (such as smoking), non-cancer diseases, environmental exposures, age, gender, race, ethnicity, socio-economic status, and other potentially confounding indications or characteristics.
+Added: Understanding and cataloging this diversity has enabled us to develop a test with a low false positive rate, cancer signal detection across many cancer types, and accurate CSO prediction.
+Added: Long-term follow-up in the studies we have launched in years past will continue to yield critical data that we believe can continue to help define the standard of care in early cancer detection.
+Added: In 2020, NHS England selected us to assist with the United Kingdom’s ambitions for early cancer detection and to assess Galleri for potential population screening on a national scale.
+Added: In 2021, we initiated the NHS-Galleri Trial, a fully enrolled prospective randomized controlled clinical utility trial of approximately 140,000 participants between the ages of 50 and 77 at the time of enrollment, to evaluate the implementation of Galleri alongside the existing NHS standard of care screenings.
+Added: Funding for the trial was provided by us.
+Added: Collaborators include Queen Mary University of London, Kings College London Cancer Prevention Trials Unit, and NHS England.
+Added: The NHS-Galleri Trial was conducted pursuant to an FDA-approved investigational device exemption (“IDE”) application.
+Added: The primary objective of the trial was to assess whether implementation of Galleri can reduce the incidence of stage 3 and 4 cancers through early cancer detection.
+Added: Secondary objectives included measuring the reduction of incidence of stage 4 cancers through early detection and collecting outcomes reported by participants with a cancer signal detected test over several timepoints.
+Added: These outcomes included an assessment of participants’ anxiety, satisfaction with Galleri, and attitudes regarding standard of care screening.
+Added: The trial aimed to enroll a representative population sample to promote health equity and was fully enrolled in just over 10 months.
+Added: The trial was designed for participants to provide three blood draws over a two-year period, with the first draw taken at enrollment.
+Added: As a randomized controlled trial, half of the trial participants received the Galleri test, and half had their blood sample stored for future analysis.
+Added: Any participant in the interventional arm with a cancer signal detected result was sent for further diagnostic workup with the NHS.
+Added: The third and final round of screening was completed in July, 2024.
+Added: The trial was overseen by an Independent Data Monitoring Committee.
+Added: The NHS previously evaluated results of an early analysis from the first screening test (the prevalent screening round) in the NHS-Galleri Trial to determine whether the results were compelling enough to commence an implementation pilot prior to the final trial results.
+Added: The results of this early analysis represented limited information from only one year of results out of the three-year trial period.
+Added: In May 2024, the NHS determined not to initiate the pilot until the final trial results are available.
+Added: The NHS will evaluate the final results from the NHS-Galleri Trial before determining whether to implement the Galleri test in the NHS .
+Added: We submitted data from the NHS-Galleri Trial, together with data from our PATHFINDER 2 study and the Bridging Analysis, to support our PMA submission for Galleri in the United States.
+Added: In May 2025, we announced positive top-line results from the prevalent screening round (first year) of the study.
+Added: Data from the prevalent screening round of the study showed a substantially higher PPV than that observed in the PATHFINDER study.
+Added: CSO accuracy and specificity were consistent with those observed in the PATHFINDER study.
+Added: There were no serious safety concerns in the NHS-Galleri prevalent screening round.
+Added: In February 2026, we announced topline results from the NHS-Galleri Trial that showed:
+Added: • While the trial did not meet its primary endpoint of statistically significant reduction in combined stage 3 and 4 cancers, there was a favorable trend toward fewer combined stage 3 and 4 cancers in a pre-specified group of 12 deadly cancers in the intervention arm after the prevalent screening round.
+Added: The pre-specified group of cancers consisted of anus, bladder, colorectal, esophagus, head and neck, liver/bile duct, lung, lymphoma, myeloma/plasma cell neoplasm, ovary, pancreas, and stomach, which together are responsible for over 60% of all cancer deaths in the United States and the United Kingdom.
+Added: • Adding Galleri to standard of care screening resulted in a substantial and clinically meaningful reduction in stage 4 diagnoses compared with standard of care alone across the pre-specified group of 12 deadly cancers.
+Added: Stage 4 diagnoses in these cancers decreased with each year of sequential screening, with a greater than 20% reduction in the second and third rounds.
+Added: • A similar stage 4 reduction overall and in each year of sequential screening was observed across all cancers.
+Added: • Annual screening with the Galleri test plus standard of care screening resulted in a four-fold improvement in the overall cancer detection rate compared to standard of care screening alone in England for (breast, colorectal, cervical and high risk lung cancer).
+Added: • A substantial increase in the number of Stage I-II cancers in the 12 pre-specified deadly cancer types that are typically found in late stages were observed in the intervention arm.
+Added: • Screening with the Galleri test resulted in a substantial reduction in the number of cancers detected clinically through emergency department presentation, which are associated with significantly higher mortality and healthcare costs.
+Added: • Test performance on PPV, CSO accuracy and false positive rate was consistent with the range reported in previous studies.
+Added: We are undertaking additional analyses to better understand these rich data, and intend to submit detailed results for presentation at the ASCO 2026 Annual Meeting.
+Added: Among other initial observations about the results, we found a higher than anticipated incidence of stage 3 cancers in the trial.
+Added: Time to diagnostic resolution did not appear to change significantly between screening rounds, and was not substantially different than our PATHFINDER 2 study.
+Added: In addition to the full data to be presented at ASCO, we plan to collect and readout additional data over time.
+Added: Based on our observation of the trends and number and distribution of cancer stages across screening rounds, we also plan to extend the follow up period by an additional 6 to 12 months, which we believe will provide additional insights as data in both the intervention and control arms mature and more cancers appear.
+Added: The design of our NHS-Galleri Trial is summarized in the figure below:
+Added: PATHFINDER 2 is a prospective, multi-center, interventional study evaluating the safety and performance of Galleri in a population of individuals aged 50 years and older who are eligible for guideline-recommended cancer screening in the United States.
+Added: We began enrolling PATHFINDER 2 in December 2021, and the study enrolled approximately 35,000 participants at 32 clinical institutions in North America.
+Added: Enrollment was completed in July, 2024.
+Added: Funding for PATHFINDER 2 was provided by us.
+Added: Collaborators include, among others, the Cleveland Clinic, Duke Health, Henry Ford Health System, Mayo Clinic, Oregon Health and Science University (OHSU), Memorial Care, Sutter Health, and the US Oncology Network.
+Added: These collaborations are subject to terms generally consistent with industry sponsored studies.
+Added: PATHFINDER 2 is being conducted pursuant to an FDA-approved IDE application.
+Added: The primary objectives of the study are to evaluate the safety of Galleri based on the number and type of diagnostic procedures performed in participants who receive a cancer signal detected but do not receive a cancer diagnosis (i.e., false positive) and to evaluate the performance of Galleri across various measures, including PPV, NPV, sensitivity, specificity, and CSO prediction accuracy, among others.
+Added: Participants who received a cancer signal detected result underwent additional diagnostic testing based on the predicted CSO to confirm if the participant does, in fact, have cancer.
+Added: Secondary objectives include, among others, collecting outcomes reported by participants over several timepoints, including an assessment of participants’ anxiety, satisfaction with Galleri, and attitudes regarding standard of care screening.
+Added: Collection was made at baseline measurement prior to testing, post-results, and post-diagnostic resolution for positive test results.
+Added: In October 2025, we presented positive PATHFINDER 2 Initial Results from the first approximately 25,000 participants in the study with 12 months of follow-up at the ESMO meeting.
+Added: Data also showed a PPV of 61.6%, substantially higher than in the previous PATHFINDER study.
+Added: The CSO accuracy of 92% and false positive rate of 0.4% were consistent with that observed in the PATHFINDER study.
+Added: Adding Galleri to recommended screenings for breast, cervical, colorectal, and lung cancers (USPSTF A and B recommendations) led to a more than seven-fold increase in the number of cancers found within a year.
+Added: Galleri detected approximately three times as many cancers when added to standard-of-care screening for breast, cervical, colorectal, lung, and prostate cancers (USPSTF A, B, and C recommendations).
+Added: Approximately three-quarters of the cancers detected by Galleri do not have standard of care screening options.
+Added: Results from the full approximately 35,000 participants in the PATHFINDER 2 study were generally consistent with the results presented at ESMO.
+Added: In January 2025, we submitted the PATHFINDER 2 Initial Results, along with the NHS-Galleri Prevalent Round Results and the Bridging Analysis, to support our PMA submission for Galleri in the United States.
+Added: The design of our PATHFINDER 2 study is summarized in the figure below:
+Added: In December 2019, we initiated PATHFINDER, a prospective, multi-center, interventional study evaluating an earlier version of Galleri in clinical practice.
+Added: The study enrolled 6,662 participants across several health systems in the United States.
+Added: Funding for PATHFINDER was provided by us.
+Added: Collaborators included, among others, the Cleveland Clinic, Dana-Farber Cancer Institute, Intermountain Healthcare, Mayo Clinic, Oregon Health & Science University, Sutter Health, and the US Oncology Network, and no serious adverse events were identified.
+Added: These collaborations were subject to terms generally consistent with industry sponsored studies.
+Added: The study evaluated the safety and performance of this earlier version of Galleri in a population of individuals aged 50 years and older divided into two cohorts:
+Added: participants with elevated cancer risk and participants with non-elevated cancer risk.
+Added: PATHFINDER was our first study that returned test results to physicians and participants, and evaluated how these test results affected diagnostic and care pathways in a screening population.
+Added: PATHFINDER was conducted pursuant to an FDA-approved IDE application involving an earlier version of Galleri.
+Added: Over the course of the study, we made refinements to the test to reduce the detection of pre-malignant hematologic conditions, which are relatively common.
+Added: Results for the study are reported for both the earlier and refined versions of the test.
+Added: Initial results from the PATHFINDER study were presented at ESMO in 2022, and full results were published in The Lancet in October 2023.
+Added: These data, in conjunction with the results from our CCGA study, supported our launch of Galleri as a LDT in the United States.
+Added: In the study, when added to current standard of care screening, Galleri more than doubled the number of cancers detected from screening.
+Added: Study results showed that 71% (25/35) of participants that received a cancer signal detected from our MCED test result had types of cancer detected that have no routine cancer screening available.
+Added: Among participants who received a cancer signal detected result and had a confirmed new cancer diagnosis (true positive), nearly half (48%) of the non-recurrent cancers were detected at an early stage (Stage I or II).
+Added: For patients with a cancer signal detected result, the predicted CSO directed diagnostic workups and helped to resolve cancer diagnosis in less than three months (median 79 days) for most participants (73%), and in less than two months (57 days) for patients with true positive results.
+Added: As expected, the median time to diagnostic resolution was longer for false positive results (162 days), with 44% of these participants scheduling follow-up imaging or procedures three or more months later, contributing to the longer time to resolution.
+Added: Notably, the first workup based on CSO facilitated a diagnostic resolution in 25 of the 32 participants who had diagnostic resolution (approximately 80%).
+Added: This group of 32 participants consisted of only those who received a cancer signal detected result from both Galleri and an earlier version of our MCED test also being studied in PATHFINDER.
+Added: Study results with the earlier version of the test showed a high PPV of approximately 38%, high (97%) CSO prediction accuracy, and the test detected 36 cancer cases in 35 patients out of 6,621 participants with analyzable results.
+Added: A pre-specified retrospective re-analysis of samples with the refined version of the test showed a higher PPV of approximately 43%, which is consistent with our CCGA study, and high (88%) CSO prediction accuracy.
+Added: Specificity was 99.1% with the earlier version of the test and 99.5% with the refined version of the test, resulting in a false positive rate of less than 1% for both versions of the test.
+Added: The design of our PATHFINDER study is summarized in the figure below:
+Added: Circulating Cell-free Genome Atlas Study (CCGA)
+Added: CCGA is our foundational observational, case-controlled study with planned five years of longitudinal follow-up.
+Added: The study was used to discover, train, and validate Galleri, and was used alongside the SYMPLIFY study to analyze performance in the symptomatic patient population to support our diagnostic aid for cancer (“DAC”) offering.
+Added: The CCGA study enrolled 15,254 participants, 56% of which had newly diagnosed cancer, inclusive of both early-and late-stage disease, and 44% of which did not have a known cancer diagnosis at the time of enrollment.
+Added: Funding for the CCGA study was provided by us.
+Added: Collaborators included, among others, the Cleveland Clinic, Dana-Farber Cancer Institute, Lahey Hospital and Medical Center, Mayo Clinic, and the US Oncology Network, and no serious adverse events were identified.
+Added: These collaborations were subject to terms generally consistent with industry sponsored studies.
+Added: We completed enrollment of our CCGA study in February 2019, and follow-up with participants is ongoing and expected to continue until 2024.
+Added: The results of CCGA, in conjunction with the results from our PATHFINDER study, supported our launch of Galleri as an LDT in the United States.
+Added: The goals of CCGA included the development and evaluation of classifiers to distinguish cancer cfDNA from non-cancer cfDNA and the identification of classifiers for the cfDNA prediction of CSO.
+Added: By enrolling people with and without cancer, we are able to characterize cfDNA profiles by tumor type and tumor stage in participants with cancer, and can compare these signals to participants without cancer.
+Added: In addition, understanding the signals associated with population diversity is important to our ability to account for biological noise and develop high-specificity tests.
+Added: For example, our machine learning algorithms are trained to distinguish patterns of cancer from technical and biological noise, which is necessary to distinguish cancer cfDNA from other cfDNA signals that are indicative of non-cancerous conditions but that may be confused with a cancer signal.
+Added: As a result, we enrolled participants with confounding indications across broad populations, and individuals with varied age, sex, cancer risk factors such as smoking status, body mass index and comorbid conditions, to increase the generalizability of this population.
+Added: We evaluated data from the CCGA study in three pre-specified sub-studies, each as described in more detail below.
+Added: The design of our CCGA study, including the three pre-specified sub-studies, is summarized in the figure below:
+Added: In CCGA-1, our first CCGA sub-study of approximately 2,800 participants, we investigated various comprehensive cfDNA-based approaches for the detection of cancer signals and the prediction of the CSO, including through targeted sequencing to analyze single nucleotide variants and small insertions and deletions;
+Added: WGS to analyze copy number variations, fragment lengths, fragment endpoints, and allelic imbalance;
+Added: and WGBS to analyze methylation patterns.
+Added: The data demonstrated that WGBS (the methylation-based assay studied) performed as well or better than the other prototype assays we tested, either alone or in combination, at both cancer signal detection and CSO prediction.
+Added: After comprehensive analysis of these whole-genome methylation patterns, we discovered highly informative and low-noise methylation regions for cancer signal detection and CSO prediction, suggesting that the methylation-based assay also had the most room for efficiency improvements.
+Added: Based on these results, our methylation technology was advanced into further development, ultimately resulting in a targeted methylation approach that had superior performance and lower costs compared to whole-genome
+Added: Data from this sub-study were shared in several oral and poster presentations at multiple major medical conferences, including at AACR, ASCO, and ESMO, and were published in Cancer Cell.
+Added: The primary objective of the CCGA-2 sub-study was to train and validate a classifier for cancer detection versus non-cancer detection, and CSO prediction, utilizing our targeted methylation assay.
+Added: This pre-specified sub-study included approximately 6,700 total participants across training and validation sets, with 4,487 participants from CCGA and 2,202 from STRIVE.
+Added: Of the total participants, 2,482 participants had previously untreated cancers and 4,207 participants did not have cancer.
+Added: More than 50 types of cancer across all clinical stages were represented.
+Added: Results from the CCGA-2 sub-study were published in the Annals of Oncology in March of 2020 (and reflected on the cover) and demonstrated that Galleri could detect a shared cancer signal across more than 50 different types of cancer, including many types of cancer that do not have recommended screenings, from a simple blood draw with very high specificity.
+Added: Data was evaluated in both training and test sets, and performance was comparable across the two analyses.
+Added: At greater than 99% specificity, Stage I-III sensitivity for a pre-specified set of 12 deadly types of cancer, which together account for approximately 63% of cancer deaths in the United States annually, was approximately 67% and for all cancers was approximately 55%.
+Added: The CSO prediction was correct in more than 90% of true positive test results.
+Added: CCGA-3, our third CCGA sub-study, was designed to further validate a version of the MCED test refined for use as a screening tool (Galleri) in a large cohort of participants with and without cancer.
+Added: This pre-specified sub-study included 4,077 participants in an independent validation set (2,823 had cancer and 1,254 did not have cancer).
+Added: Specificity, sensitivity, and CSO prediction accuracy were measured.
+Added: Results of the CCGA-3 sub-study were published in the Annals of Oncology in June of 2021, and confirmed that Galleri detects a shared cancer signal across more than 50 different types of cancer.
+Added: Specificity for cancer signal detection was 99.5%.
+Added: Stage I-III sensitivity for a pre-specified set of 12 deadly types of cancer, which together account for approximately 63% of cancer deaths in the United States annually, was approximately 68% and for all cancers was approximately 41%.
+Added: The overall sensitivity for cancer signal detection was 52%.
+Added: As expected, and as previously observed, sensitivity increased with stage (stage I:
+Added: 16.8%, stage II:
+Added: 40.4%, stage III:
+Added: 77.0%, stage IV:
+Added: The CSO prediction was correct in approximately 89% of true positive test results.
+Added: STRIVE is a prospective, observational, longitudinal cohort study in the United States that enrolled 99,481 women without a known cancer at the time of enrollment.
+Added: Samples from a subset of women will be used to help further validate Galleri in an asymptomatic and intended use population.
+Added: This study was initiated in February 2017 and completed enrollment in November 2018.
+Added: Funding for the study is provided by us.
+Added: Collaborators include, among others, the Cleveland Clinic, Henry Ford Health System, Mayo Clinic, and Sutter Health, and no serious adverse events have been identified.
+Added: These collaborations are subject to terms generally consistent with industry sponsored studies.
+Added: Each participant had a blood draw at the time of their regular screening mammogram.
+Added: Participants diagnosed with any type of cancer had additional blood draws.
+Added: Participants were followed for 30 months and thereafter, if they developed cancer, through state and national cancer registries.
+Added: We collected demographic information, such as age, race, and ethnicity, in addition to clinical information, such as cancer diagnoses, treatment, cancer-specific mortality, and overall survival.
+Added: We utilized 2,202 samples for validation of an earlier version of Galleri and used 4,891 samples in a training set to support the version of Galleri we launched as an LDT.
+Added: We have not used other samples to analyze or validate performance in an asymptomatic and intended use population to date, and thus we have not reported any interim findings or results from STRIVE.
+Added: We plan to leverage the long-term follow up to help us understand how best to optimally use the remaining samples.
+Added: SUMMIT is a prospective, observational, longitudinal cohort study that is being conducted in and around London, United Kingdom.
+Added: Funding for the study is provided by us.
+Added: Collaborators include University College London and University College London Hospitals, and no serious adverse events have been identified.
+Added: These collaborations are subject to terms generally consistent with industry sponsored studies.
+Added: The study is designed to further validate Galleri as an MCED test, including for lung and other smoking-related cancers, and to assess the feasibility of low-dose computed tomography (“LDCT”) lung cancer screening in the United Kingdom.
+Added: This study was initiated in April 2019 and completed enrollment in May 2023.
+Added: The study enrolled 13,035 men and women between the ages of 50 and 77 who did not have a cancer diagnosis at the time of enrollment.
+Added: Participants in the study are individuals at high risk for lung cancer due to significant smoking history based on validated risk scores.
+Added: Participants provided three serial (annual) blood draws and are being followed annually for three years and then for a further five years through national health registries as well as medical records.
+Added: The primary objective is to measure cancer incidence, which will be used to assess the test performance for sensitivity, specificity, PPV, and NPV.
+Added: Our SUMMIT study may also demonstrate the utility of MCED testing in a high-risk population by comparing performance of Galleri in detecting lung and other smoking-related cancers to that of LDCT.
+Added: We expect to report interim results from the SUMMIT study in 2026 or 2027.
+Added: REFLECTION is a multi-center, prospective, observational cohort study of patients administered Galleri as part of their medical care in a real-world setting in the United States that enrolled approximately 14,000 individuals.
+Added: The purpose of the study was to evaluate and understand the real-world experience with Galleri in clinical settings.
+Added: The objectives of the study are to describe cancer signal detection and CSO prediction within and across sites among participants who opt to receive Galleri in a real-world setting, to assess the feasibility and acceptability of Galleri from the perspective of participants and patient-reported outcomes, and to assess healthcare resource utilization associated with diagnostic workups for participants that receive a cancer signal detected result.
+Added: We began enrolling the REFLECTION study in August 2021 and enrollment was completed in September, 2025.
+Added: Funding for the study is provided by us.
+Added: Collaborators include, or have previously included, Carolina Blood and Cancer Care Associates, Providence, U.S.
+Added: Department of Veterans Affairs, and Vincere Cancer Center.
+Added: These collaborations are subject to terms generally consistent with industry sponsored studies.
+Added: No serious study-related adverse events have been identified.
+Added: Initial results from 2,854 participants in the study were presented in October 2024 at the Early Detection of Cancer Conference.
+Added: In this initial cohort, the cancer signal detection rate was 1.30% (37/2854 participants;
+Added: 0.94% – 1.78%), which is consistent with other populations that have received the MCED test.
+Added: Among the 37 participants with a Cancer Signal Detected (CSD) at the time of analysis, 28 completed 180 days of follow-up, and of these, 12 cancer diagnoses were confirmed.
+Added: More than half of the cases were identified at early stages (I-III) and the most common cancer signal of origin prediction was lung cancer (7).
+Added: Positive predictive value was 42.9%, consistent with PPVs from previous Galleri testing datasets.
+Added: Additional results from an expanded cohort of 3,355 participants were presented in October of 2025 at the Early Detection of Cancer Conference.
+Added: In this expanded cohort, the cancer signal detection rate was 0.89% (30/3355 participants;
+Added: 0.63 – 1.27%), in-line with other populations that have received the MCED test.
+Added: Among the 30 participants with a Cancer Signal Detected result, 15 had a confirmed cancer diagnosis, resulting in a PPV of 50%, consistent with other clinical studies and real world evidence.
+Added: Of the 14 confirmed new cancers, 57.1% (8/14) were detected at stages I or II.
+Added: The CSO accuracy remained high at 93.3%.
+Added: Additional cancers could be diagnosed during the remainder of the one-year follow-up period for the cohort.
+Added: The design of our REFLECTION study is summarized in the figure below:
+Added: SYMPLIFY evaluated the performance of MCED in symptomatic patients in the United Kingdom that were referred from the primary care setting due to clinical suspicion of cancer.
+Added: This patient population represents a distinct patient population from Galleri’s targeted asymptomatic screening population.
+Added: This study was initiated in July 2021 and completed enrollment in November 2021.
+Added: The SYMPLIFY study enrolled 6,238 participants aged 18 years and older in England and Wales.
+Added: Funding for the study is provided by us.
+Added: Collaborators include Oxford University.
+Added: This collaboration is subject to terms generally consistent with industry sponsored studies.
+Added: Participants were referred for urgent imaging, endoscopy or other diagnostic modalities to investigate symptoms suspicious for possible gynecological, lung, lower GI or upper GI cancer, or who presented with non-specific symptoms.
+Added: The most commonly reported symptoms leading to referral were unexpected weight loss (24.1%), change in bowel habit (22.0%), post-menopausal bleeding (16.0%), rectal bleeding (15.7%), abdominal pain (14.5%), pain (10.6%), difficulty swallowing (8.8%), and anemia (7.1%).
+Added: In the study, the MCED test’s cancer signal detected and CSO prediction results were compared with diagnoses results obtained through standard of care pathways.
+Added: Data from the study demonstrated strong performance in this symptomatic population, and supported the feasibility of using an MCED test to assist clinicians with decisions regarding referrals from primary care.
+Added: Data from the SYMPLIFY study were presented at ASCO in 2023 (in a podium presentation) and published in The Lancet Oncology, and we are using the results to support the development and launch of DAC.
+Added: In the study, 368 (6.7%) of the 5,461 evaluable patients were diagnosed with cancer through standard of care pathways.
+Added: The most common cancer diagnoses were colorectal (37.2%), lung (22.0%), uterine (8.2%), esophago-gastric (6.0%) and ovarian (3.8%).
+Added: Our test detected a cancer signal in 323 participants, and cancer was diagnosed in 244 of these participants.
+Added: The test demonstrated a PPV of approximately 75%, NPV of approximately 98%, sensitivity of approximately 66%, specificity of approximately 98%, and CSO prediction accuracy of approximately 90%.
+Added: Among participants in the study, 6.7% of enrolled participants were eventually diagnosed with cancer, having already been referred by their primary care physician for investigation.
+Added: In October 2025, we presented long-term results from an extended registry follow-up of the SYMPLIFY study at the Early Detection of Cancer Conference (EDCC) in Portland, Oregon.
+Added: Patients reported to have a false positive Galleri result were followed for 24 months in national cancer registries for England and Wales.
+Added: The analysis showed that 35.4% (28 of 79 participants) were later diagnosed with cancer within 24 months of enrollment.
+Added: This reduction in false positives from 79 to 51 resulted in an increase of PPV to 84.2%.
+Added: Of those 28 participants, 27 had an accurate CSO prediction.
+Added: Additional results include:
+Added: • 16 of the 28 (57.1%) were diagnosed with cancer within nine months of enrollment.
+Added: ◦ Eight of the 16 (50%) were diagnosed with cancers that were correctly predicted by the Galleri test’s CSO finding, but were incongruent with the diagnostic pathway chosen by the general practitioner based on the participants’ presenting symptoms.
+Added: • 12 of the 28 (42.9%) were diagnosed 10-24 months after enrollment.
+Added: ◦ Seven of the 12 (58.3%) were diagnosed outside the original referral pathway;
+Added: in those cases, the CSO also was correct, matching the site that was ultimately diagnosed.
+Added: The design of our SYMPLIFY study is summarized in the figure below:
+Added: The REACH/Galleri-Medicare study is intended to evaluate the impact of Galleri in a population of Medicare beneficiaries.
+Added: The study has a unique design where up to 50,000 participants will be enrolled and receive Galleri, up to three annual tests.
+Added: A comparator arm of approximately 50,000 individuals matched for certain characteristics will be generated, and the rate of stage IV cancers will be compared between arms.
+Added: Additional endpoints focus on performance, participant reported outcomes, and health care resource utilization.
+Added: The study is being conducted under an investigational device exemption (IDE).
+Added: Galleri screening tests are reimbursed by CMS.
+Added: The study began enrolling in July 2024 and is ongoing.
Commercialization
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We launched Galleri in the United States in mid-2021.
−Removed: As of December 31, 2024, we have sold more than 290,000 commercial tests, including more than 137,000 tests in 2024, and established a number of commercial partnerships, including leading healthcare systems, employers, payors, and life insurance providers.
+Added: As of December 31, 2025, we have sold more than 475,000 commercial tests, including more than 185,000 tests in 2025 and established a number of commercial partnerships, including leading healthcare systems, employers, digital health platforms, payors, and life insurance providers.
As of December 31, 2025, our commercial organization included approximately 250 personnel supporting our multi-channel strategy.
18 unchanged sentences
We believe our experience with these partners will allow us to rapidly scale upon broad reimbursement for Galleri.
−Removed: Life insurance providers .
−Removed: We have partnered with several leading life insurance providers to provide Galleri to their policyholders.
−Removed: Life insurers are committed to helping customers live longer, healthier, better lives and understand that preventative care and early detection are key to that mission.
−Removed: Galleri is offered by these providers as a preventative health benefit and is not used for underwriting, risk assessment or risk pooling.
We have announced pilot or benefit programs with leading payors and continue to engage with other progressive payors.
2 unchanged sentences
This also includes early-adopting commercial payors.
+Added: International Strategy .
+Added: We enable access to Galleri in various countries outside of the United States through a global network of local and regional partners.
+Added: Our partners assist with blood draw, sample logistics, sales and marketing, and customer support to serve patients, providers, and insurers in their markets.
+Added: Market entry through our partners is subject to regulatory clearance of the Galleri test.
+Added: Digital Health.
+Added: The Galleri test is offered by a number of digital health and telemedicine platforms that seek to provide consumer-facing healthcare products and services to cash paying patients, often anchored on a lab-based wellness and longevity offering.
+Added: We believe these consumer platforms see Galleri as a complementary offering that supports their value proposition and enhances credibility with their members.
+Added: These partners, with their focus and core competencies around member acquisition, engagement and retention, allow GRAIL to substantially (and cost-effectively) increase awareness and REACH of the Galleri test to a broader cohort of health seeking patients who can benefit from MCED screening.
First Responders .
We have worked with clinics, fire departments, municipalities, and unions to make Galleri available to firefighters who generally have exposure-related increased risk of cancer and are actively screening their populations and seeking new approaches.
+Added: Life insurance providers .
+Added: We have partnered with several leading life insurance providers to provide Galleri to their policyholders.
+Added: Life insurers are committed to helping customers live longer, healthier, better lives and understand that preventative care and early detection are key to that mission.
+Added: Galleri is offered by these providers as a preventative health benefit and is not used for underwriting, risk assessment or risk pooling.
+Added: In addition, we aim to use value-oriented partnerships, such as our integration with Quest to provide a simpler blood draw process and our planned integration with EPIC to simplify provider ordering, to help make Galleri even more accessible.
+Added: We believe these partnerships can help Galleri be easily integrated into routine practice, where healthcare providers can order Galleri as part of an annual examination.
Reimbursement Landscape for Screening Tests
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Traditional fee-for-service Medicare generally does not cover screening tests, which are considered preventive services, that are performed in the absence of signs or symptoms of illness or injury, unless there is a statutory provision that explicitly authorizes coverage of the test.
−Removed: The Medicare Improvements for Patients and Providers Act of 2008 authorizes the Centers for Medicare and Medicaid Services (“CMS”) to cover additional preventive services that are not expressly covered by the statute if the service is (a) reasonable and necessary for the prevention or early detection of an illness or disability, (b) recommended with a grade of A or B by the USPSTF, an independent, volunteer panel of experts in the field of prevention, evidence-based medicine and primary care, and (c) appropriate for Medicare beneficiaries under Part A or Part B.
−Removed: CMS establishes coverage through a national coverage determination (“NCD”) process.
+Added: In February 2026, the Nancy Gardner Sewell Medicare MCED Coverage Act became law and created a Medicare coverage benefit category for multi-cancer early detection tests.
+Added: The law included certain standards, including that Centers for Medicare and Medicaid Services (“CMS”) would establish coverage through a national coverage determination (“NCD”) process under “reasonable and necessary” evidentiary requirements.
+Added: An NCD typically involves a multi-step review that can include evidence assessment by CMS staff, consultation with external technology assessment organizations, a Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) meeting, and opportunities for public comment.
+Added: CMS may issue an NCD to provide coverage for MCED tests that are cleared under 510(k), classified under 513(f)(2) or approved by the FDA, with authority to initiate coverage as early as January 1, 2029, although any NCD may be delayed or be more restrictive than the full authority provided by statute.
+Added: Coverage eligibility is phased in, with those aged 50-65 eligible under the law in 2029, expanding by one age-year annually.
+Added: The payment rate for covered MCED tests would be in alignment with methodologies under the Protecting Access to Medicare Act (PAMA), which incorporates private market rates.
+Added: Galleri is currently offered as an LDT in our CAP-accredited and CLIA-certified laboratory.
+Added: We have a Breakthrough Device designation with the FDA and, in January 2026, we submitted a PMA to the FDA.
+Added: Nonetheless, no version of Galleri has been approved or cleared by the FDA and obtaining PMA approval can take several years, if at all, from the time the PMA was submitted.
+Added: Galleri may not be approved on our expected timeline or at all.
+Added: The Medicare Improvements for Patients and Providers Act of 2008 also authorizes CMS to cover additional preventive services that are not expressly covered by the statute if the service is (a) reasonable and necessary for the prevention or early detection of an illness or disability, (b) recommended with a grade of A or B by the USPSTF, an independent, volunteer panel of experts in the field of prevention, evidence-based medicine and primary care, and (c) appropriate for Medicare beneficiaries under Part A or Part B.
In its discretion, the USPSTF generally waits for FDA authorization before it considers undertaking reviews of novel technology.
−Removed: Because MCED is not expressly authorized for coverage by the Medicare statute, one possible pathway for Medicare reimbursement is to first obtain FDA approval and then obtain a grade of A or B recommendation from USPSTF, to enable CMS to issue an NCD.
+Added: Outside of the recently enacted MCED coverage category, another possible pathway for Medicare reimbursement is to first obtain FDA approval and then obtain a grade of A or B recommendation from USPSTF, to enable CMS to issue an NCD.
The last cancer screening test to receive a recommendation from USPSTF with a grade A/B and obtain Medicare coverage was LDCT to screen high-risk smokers for lung cancer in 2015.
−Removed: Medicare coverage can also be changed by statute, thus a second possible pathway for Medicare reimbursement would be to amend the Medicare statute to cover MCED.
−Removed: This process would generally require new legislation to expressly authorize CMS to cover FDA-approved early cancer screening and detection tests.
−Removed: We are working with stakeholders to advance and shape the public reimbursement landscape to reflect that additional scope of coverage.
−Removed: Galleri is currently offered as an LDT in our CAP-accredited and CLIA-certified laboratory.
−Removed: We have a Breakthrough Device designation with the FDA and have begun the modular PMA submission process, which we expect to conclude with data from our ongoing pivotal studies.
−Removed: Under our Breakthrough Designation, interactions with the FDA have resulted in an anticipated timeline to submission, which we anticipate making in the first half of 2026.
−Removed: Nonetheless, the FDA requirements that will govern multi-cancer detection tests, as well as the breadth and nature of data we must provide the FDA, to support the proposed intended use, may be subject to change, and as such, it is difficult to predict what information we will need to submit to obtain approval of a PMA from the FDA for a proposed intended use.
−Removed: Following FDA approval and assuming a statutory change in the reimbursement landscape, we plan to pursue broad reimbursement, for example, through Medicare reimbursement, and subsequently pursue inclusion of Galleri in the USPSTF guideline recommendation.
+Added: Even if we were to obtain CMS coverage through the new MCED test category, we expect to seek USPSTF recommendation because of its role in setting standard of care.
+Added: Should USPSTF recommend Galleri for a more expansive population than what is covered under the MCED benefit category, CMS would then have the authority to expand coverage following a USPSTF A/B recommendation.
+Added: If FDA approval is obtained, we plan to pursue broad reimbursement, for example, through Medicare reimbursement, and subsequently pursue inclusion of Galleri in the USPSTF guideline recommendation.
United Kingdom—Commercial agreement with NHS
3 unchanged sentences
The primary objective of the trial is to assess whether implementation of Galleri can reduce the incidence of late-stage cancers through early cancer detection.
−Removed: The NHS will evaluate the final results from the NHS-Galleri Trial, which are expected to be available in 2026, alongside other factors before determining whether to implement the Galleri test in the NHS.
+Added: The NHS will evaluate the final results from the NHS-Galleri Trial, for which we announced topline results in February 2026, alongside other factors before determining whether to implement the Galleri test in the NHS.
+Added: We believe the decision may include, in addition to an evaluation of the final results, considerations such as NHS budget, political priorities, cost-effectiveness and implementation constraints.
+Added: Under our agreement with the NHS, these results have met certain success criteria and missed others.
+Added: As a result, we and NHS are required to establish a joint steering committee that will discuss how best to proceed with deployment to the UK population, if at all, considering deployment approaches and which population groups would most benefit.
In the event that we proceed with commercial implementation following such results, we expect that our partnership with the NHS would be our first national system implementation.
1 unchanged sentence
The results of this early analysis represented limited information from only one year of results out of the three-year trial period, and final results from the full three-year period may differ from the early analysis for a variety of reasons.
−Removed: In May 2024, the NHS determined not to initiate the pilot on the basis of those available data.
+Added: In May 2024, the NHS determined not to initiate the pilot on the basis of the available data.
Given that the NHS has a reputation for high evidence standards for new technologies, we anticipate that NHS approval and implementation could expand adoption in the United Kingdom and could also help facilitate adoption in other single payor systems around the world.
1 unchanged sentence
Other International
−Removed: In December 2024, we launched the sale of Galleri in Israel using a distributor model.
+Added: In December 2024, we launched Galleri in Israel in partnership with a distributor, although current geopolitical conflicts have impacted recent sales.We subsequently expanded into Canada with a partner in October 2025.
+Added: Also in October 2025, we announced subject to final execution of definitive agreements, that we will work with Samsung C&T as exclusive partners to commercialize the Galleri test in South Korea, with a possible extension into other Asian geographies, including Japan and Singapore.
We intend to explore the launch of Galleri in select other international geographies, including through distributors.
Significant Investments for Scale
−Removed: We have made significant investments for scale in our CAP-accredited and CLIA-certified laboratory facility in Durham, North Carolina and demonstrated execution with more than 600,000 clinical and commercial individual samples processed through December 31, 2024.
−Removed: We have an established footprint in the United States and United Kingdom, with operations in Durham, North Carolina, Washington, D.C., and London, United Kingdom.
−Removed: In total we have approximately 46,000 square feet of CAP-accredited, CLIA-certified laboratory space with sufficient capacity to support multiple years of growth at our Durham facility.
+Added: We have made significant investments for scale in our CAP-accredited and CLIA-certified laboratory facility in Durham, North Carolina and demonstrated execution with more than 800,000 clinical and commercial individual samples processed from launch through December 31, 2025.
+Added: We have an established footprint in the United States and the United Kingdom, with our headquarters in Menlo Park, California and operations in Durham, North Carolina, Washington, D.C., and London, United Kingdom.
+Added: In total we have approximately 46,000 s quare feet of CAP-accredited, CLIA-certified laboratory space with sufficient capacity to support multiple years of growth at our Durham facility.
We have made significant investments to our Durham laboratory to improve the automation, including development of a fully automated laboratory testing platform consisting of robotic work cells connected by a central track system to increase efficiencies and reduce costs.
+Added: We believe this scalable infrastructure is capable of meeting significant demand of up to one million tests per year.
Our lab operates 16 hours a day, seven days a week, and uses automation and other technology to reduce staff exposure to complicated, dangerous, repetitive, or injury-prone work.
In 2024, we also launched an updated version of Galleri increasing the amount of laboratory automation, among other improvements.
+Added: In connection with implementation of this new version of Galleri, we have experienced and may continue to experience increased turnaround times, re-processing costs and sample failures.
+Added: We continually monitor and evaluate laboratory operations and performance in an effort to achieve our intended sample processing metrics and costs;
+Added: however from time to time, processing issues may arise that could impact our operations.
+Added: In the future, it is possible that we may invest significant amounts in infrastructure to support new products or existing products in new markets.
We believe that our current facilities are sufficient to meet our current and anticipated near-term needs.
19 unchanged sentences
GRAIL sole-source suppliers include Illumina, Inc.
−Removed: who is our sole supplier of sequencers and certain laboratory reagents, Madison, who acquired our blood collection tube manufacturer Streck, Inc.
−Removed: in 2023 and who is our sole supplier of tubes used for sample collection, and Twist who is the sole supplier of our DNA probes.
+Added: who is our sole supplier of sequencers and certain laboratory reagents, Madison Industries (“Madison”), who acquired our blood collection tube manufacturer Streck, Inc.
+Added: in 2023 and who is our sole supplier of tubes used for sample collection, and Twist Biosciences Corporation (“Twist”) who is the sole supplier of our DNA probes.
We rely on standard commercial carriers for the delivery of samples to our laboratory.
2 unchanged sentences
Pursuant to the Illumina Supply Agreement, Illumina granted us non-exclusive rights to use certain Illumina know-how and technology with Illumina products purchased under the agreement.
−Removed: Under the terms of the Illumina Supply Agreement, regardless of whether our products incorporate any Illumina technology, we were obligated to pay Illumina a high single-digit
−Removed: royalty, subject to certain reductions and floors, in perpetuity on net sales generated by our products or revenues otherwise generated or received by us, subject to certain exceptions, in the field of oncology.
−Removed: Pursuant to the fourth amendment to the Illumina Supply Agreement, the perpetual royalty payment obligation to Illumina is suspended until December 24, 2026 or any earlier change of control of GRAIL, at which time royalty payments to Illumina will resume, without retroactive effect.
−Removed: In addition, upon the execution of such amendment, we may elect to purchase instruments, supplies, and services from Illumina either pursuant to Illumina’s “Open Offer” universal pricing terms applicable to all of its for-profit oncology customers in the United States since March 2021, as updated, or the pricing terms we had prior to Illumina’s acquisition of us.
+Added: Under the terms of the Illumina Supply Agreement, regardless of whether our products incorporate any Illumina technology, we will be obligated to pay Illumina a 9% royalty, subject to certain reductions and floors, in perpetuity on net sales generated by our products or revenues otherwise generated or received by us, subject to certain exceptions, in the field of oncology.
+Added: The royalty is subject to anti-stacking provisions that allow royalty payments we make to other third parties to be deducted from the 9% royalty rate, to a floor of 7%.
+Added: We expect that the third party royalty payments we will make in the foreseeable future will result in a 7% royalty rate.
+Added: After we have cumulatively paid Illumina royalties totaling $1 billion, the royalty rate will be reduced to 5%, without further adjustment.- Pursuant to the fourth amendment to the Illumina Supply Agreement, the perpetual royalty payment obligation to Illumina is suspended until December 24, 2026 or any earlier change of control of GRAIL, at which time royalty payments to Illumina will resume without retroactive effect.
+Added: Any royalty payments that we would have made under the Illumina Supply Agreement during the suspension period are deemed to have been paid for purposes of the cumulative $1 billion in royalty payments required to reduce the royalty rate to 5%.
+Added: In addition, upon the execution of such amendment, we were permitted to elect to purchase instruments, supplies, and services from Illumina either pursuant to Illumina’s “Open Offer” universal pricing terms applicable to all of its for-profit oncology customers in the United States since March 2021, as updated, or the pricing terms we had prior to Illumina’s acquisition of us.
+Added: The initial term of the Illumina Supply Agreement is scheduled to expire on February 28, 2027.
+Added: The Illumina Supply Agreement will automatically renew for two year terms unless we or Illumina provide written notice of non-renewal at least 120 days prior to the end of the then-current term.
+Added: Our royalty obligations under the Illumina Supply Agreement will survive any termination.
For further discussion of the risks relating to these relationships, see “Risk Factors—Risks Relating to Our Business and Industry .”
Industry Participants
−Removed: There are other companies, such as Adela, Inc., Clearnote Health, DELFI Diagnostics, Inc., Exact Sciences Corporation, Exai Bio, Inc., Freenome Inc., Guardant Health, Inc., Harbinger Health and Natera, Inc.
+Added: There are market participants in the cancer detection space both in the United States and abroad, including Exact Sciences Corporation (recently announced to be acquired by Abbott Laboratories) and Guardant Health, Inc., who have each introduced MCED products into the market in 2025.
+Added: A number of other companies, including Caris Life Sciences, Clearnote Health and Natera, Inc.
+Added: in the United States and, Insighta, Mirxes and Seekin, Inc.
+Added: outside of the United States, have announced intentions to develop or launch MCED products.
+Added: In addition, companies, such as Adela, Inc., Clearnote Health, DELFI Diagnostics, Inc., Exai Bio, Inc., Freenome Inc., Guardant Health, Inc., Harbinger Health and Natera, Inc.
within the United States and AnchorDx, Anpac Bio-Medical Science Co., Ltd., Burning Rock Biotech Limited, Datar Cancer Genetics, Elypta AB, Gene Solutions JSC, Insighta, Mirxes, Singlera Genomics, Inc.
and Seekin, Inc.
−Removed: outside of the United States, among others, that are attempting to develop tests to detect certain types of cancer early, including some that will use cfDNA analyses.
−Removed: A number of these companies, including Guardant Health, Inc., Exact Sciences Corporation, Natera, Inc.
+Added: outside of the United States, among others, that are attempting to develop tests to detect certain types of cancer early, including some that will use cfDNA analyses, although these products are not necessarily MCED products.
+Added: A number of these companies, including Natera, Inc.
and Clearnote Health in the United States and, Insighta, Mirxes and Seekin, Inc.
13 unchanged sentences
Our success depends in part on our ability to obtain and maintain intellectual property protection for our products and technology, including by seeking and maintaining patent protection, protecting our trade secrets and other proprietary information, obtaining and maintaining our licenses to use intellectual property owned by third parties, and continually evaluating third-party technologies for further licensing opportunities.
−Removed: trademark protection where appropriate to protect the names that identify us as the source of our products and services.
+Added: We also seek trademark protection where appropriate to protect the names that identify us as the source of our products and services.
We own certain patents, patent applications, and other intellectual property, and also exclusively license certain patents, patent applications, and other intellectual property from third parties, including the Chinese University of Hong Kong.
−Removed: Our patent portfolio broadly relates to methods, techniques, systems, and chemistry used to generate and analyze data using our proprietary bioinformatics and classifiers, including, for example, cfNA sequencing, marker panels, methylation signatures, bioinformatics techniques and biologically directed machine learning classifiers, which are incorporated into or used for Galleri, our precision oncology portfolio, and a diagnostic aid for cancer (“DAC”).
+Added: Our patent portfolio broadly relates to methods, compositions, techniques, systems, and chemistry used to generate and analyze data using our proprietary bioinformatics and classifiers, including, for example, cfNA sequencing, marker panels, methylation signatures, bioinformatics techniques and biologically directed machine learning classifiers, which are incorporated into or used for Galleri, our precision oncology portfolio, and DAC.
We have also entered into certain supply and commercial agreements with various vendors and suppliers, including Illumina, under which we receive rights to their intellectual property for use in our products.
Our material licenses and other agreements are described in more detail below.
−Removed: As of December 31, 2024, we own or co-own more than 220 issued or granted patents and more than 620 pending patent applications globally, including 45 issued U.S.
−Removed: patents, 176 patents granted across Austria, Australia, Belgium, Canada, Switzerland, China, Czech Republic, Denmark, Germany, Europe, Finland, France, the United Kingdom, Greece, Hong Kong, Indonesia, Ireland, Italy, Japan, Lichtenstein, Lithuania, Luxembourg, Malaysia, Netherlands, Norway, Poland, Portugal, Sweden, Spain, Singapore, Slovenia, Slovakia, Türkiye and Taiwan, and more than 140 pending U.S.
+Added: As of December 31, 2025, we own or co-own more than 221 issued or granted patents, including 55 issued U.S.
+Added: patents and 166 patents granted across Austria, Australia, Belgium, Canada, Switzerland, China, Czech Republic, Denmark, Germany, Europe, Finland, France, the United Kingdom, Greece, Hong Kong, Indonesia, Ireland, Italy, Japan, Lichtenstein, Lithuania, Luxembourg, Malaysia, Netherlands, Norway, Poland, Portugal, Sweden, Spain, Singapore, Slovenia, Slovakia, Türkiye and Taiwan.
+Added: We also own or co-own more than 325 pending patent applications globally, including more than 132 pending U.S.
non-provisional and provisional patent applications.
−Removed: We also have exclusive licenses to approximately 630 issued or granted patents and more than 190 pending patent applications globally, including 55 issued U.S.
−Removed: patents and 575 patents granted across Albania, Austria, Australia, Belgium, Bulgaria, Brazil, Canada, Switzerland, China, Cyprus, Czech Republic, Germany, Denmark, Eurasia, Europe, Estonia, Spain, Finland, France, the United Kingdom, Greece, Hong Kong, Croatia, Hungary, Indonesia, Ireland, Israel, India, Iceland, Italy, Japan, Republic of Korea, Lithuania, Luxembourg, Latvia, Monaco, North Macedonia, Macao, Malta, Mexico, Malaysia, Netherlands, Norway, New Zealand, Philippines, Poland, Portugal, Romania, Serbia, Sweden, Singapore, Slovenia, Slovakia, San Marino, Türkiye, Taiwan, and South Africa, and more than 35 pending U.S.
+Added: We also have exclusive licenses to approximately 408 issued or granted patents, including 55 issued U.S.
+Added: patents and 353 patents granted across Australia, Brazil, Canada, China, Eurasia, Europe (including national patents and Unitary Patents covering Albania, Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, the United Kingdom, Greece, Croatia, Hungary, Ireland, Iceland, Italy, Lithuania, Luxembourg, Latvia, Monaco, North Macedonia, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Switzerland, Sweden, Slovenia, Slovakia, San Marino, and Türkiye), Hong Kong, Indonesia, Israel, India, Japan, Republic of Korea, Macao, Mexico, Malaysia, New Zealand, Philippines, Singapore, Taiwan, and South Africa;
+Added: and more than 79 pending patent applications globally, including more than 35 pending U.S.
non-provisional and provisional patent applications.
We believe these patents cover, and that these patent applications upon grant will cover, various aspects of Galleri, our precision oncology portfolio and future products or improvements to existing products that we may develop.
−Removed: Of particular importance within our sizeable patent portfolio are patents that relate to various aspects of Galleri and our precision oncology portfolio.
−Removed: • with respect to methylation analysis, which is a foundational technology underlying our current products, we own or exclusively license 144 granted patents directed to systems, software, methods, mixtures, or kits for methylation analysis in Austria, Australia, Belgium, Brazil, Canada, Switzerland, China, Czech Republic, Germany, Denmark, Eurasia, Europe, Spain, Finland, France, the United Kingdom, Greece, Hong Kong, Croatia, Hungary, Indonesia, Ireland, Israel, Iceland, Italy, Japan, Republic of Korea, Liechtenstein, Lithuania, Luxembourg, Mexico, Malaysia, Netherlands, Norway, New Zealand, Poland, Portugal, Sweden, Singapore, Slovenia, Slovakia, Türkiye, Taiwan, the United States, and South Africa.
+Added: Of particular importance within our sizable patent portfolio are patents that relate to various aspects of Galleri and our precision oncology portfolio.
+Added: • with respect to methylation analysis, which is a foundational technology underlying our current products, we own or exclusively license 156 issued or granted patents worldwide directed to systems, software, methods, compositions, mixtures, or kits for methylation analysis.
These patents are expected to expire between 2033 and 2043, subject to our payment of applicable maintenance fees and annuities;
−Removed: • with respect to our technology for determining cancer type through identification of cancer signal of origin, we own or exclusively license 65 granted patents directed to systems, software, methods, or kits for determining cancer signal of origin in Austria, Australia, Belgium Switzerland, China, Cyprus, Czech Republic, Germany, Denmark, Europe, Spain, Finland, France, the United Kingdom, Greece, Hungary, Ireland, Israel, Iceland, Italy, Japan, Republic of Korea, Lithuania, Luxembourg, Latvia, Monaco, North Macedonia, Malta, Mexico, Malaysia, Netherlands, Norway, Poland, Portugal, Sweden, Singapore, Slovenia, Türkiye, Taiwan, and the United States.
+Added: • with respect to our technology for determining cancer type through identification of cancer signal of origin, we own or exclusively license 75 issued or granted patents worldwide directed to systems, software, methods, or kits for determining cancer signal of origin.
These patents are expected to expire between 2035 and 2041, subject to our payment of applicable maintenance fees and annuities;
−Removed: • with respect to our assay chemistry and techniques for preparing and optimizing patient samples for analysis, we own or exclusively license 37 granted patents directed to methods, assay panels, compositions, or software for assay chemistry and techniques in Belgium, Switzerland, China, Germany, Europe, France, the United Kingdom, Hong Kong, Netherlands, Sweden, and the United States.
−Removed: patents are expected to expire between 2034 and 2042, subject to our payment of applicable maintenance fees and annuities.
−Removed: Our patent portfolio also includes granted patents and pending patent applications directed to other technologies that may have varying levels of importance to our current and future products, including, for example:
−Removed: • systems, methods, kits, mixtures, and probes for sequencing, library preparation and enrichment (27 patent families with 81 granted patents and 53 pending applications;
−Removed: granted patents expected to expire between 2027 and 2042);
−Removed: • methods and nucleic acid constructs for error correction for identifying somatic variants (3 patent families with 54 granted patents and 15 pending applications;
−Removed: granted patents expected to expire between 2030 and 2040);
−Removed: • systems and methods for variant based assessment of cancer (12 patent families with 48 granted patents and 56 pending applications;
−Removed: granted patents expected to expire between 2033 and 2041);
−Removed: • systems, software, and methods for sequencing based assessment of copy number aberrations in cancer (9 patent families with 91 granted patents and 47 pending applications;
−Removed: granted patents expected to expire between 2028 and 2042);
−Removed: • systems, software, and methods for fragment length assessment in cancer detection (11 patent families with 119 granted patents and 92 pending applications;
−Removed: granted patents expected to expire between 2031 and 2040);
−Removed: • systems, software, methods, and compositions for fragmentation based assessment of cancer (9 patent families with 47 granted patents and 81 pending applications;
−Removed: granted patents expected to expire between 2030 and 2039);
−Removed: • systems, software, and methods for viral based assessment of cancer (6 patent families with 24 granted patents and 54 pending applications;
−Removed: granted patents expected to expire between 2038 and 2040).
+Added: • with respect to our assay chemistry and techniques for preparing and optimizing patient samples for analysis, we own or exclusively license 60 granted or issued patents worldwide directed to methods, assay panels, compositions, or software for assay chemistry and techniques.
+Added: These patents are expected to expire between 2037 and 2040, subject to our payment of applicable maintenance fees and annuities.
+Added: Our patent portfolio also includes 337 granted or issued patents worldwide, directed to other technologies that relate to our current and future products, including, for example:
+Added: systems, methods, kits, mixtures, and probes for sequencing, library preparation and enrichment;
+Added: methods and nucleic acid constructs for error correction for identifying somatic variants;
+Added: systems and methods for variant based assessment of cancer;
+Added: systems, software, and methods for sequencing based assessment of copy number aberrations in cancer;
+Added: systems, software, methods, and compositions for fragmentation based assessment of cancer;
+Added: and systems, software, and methods for viral based assessment of cancer.
+Added: These patents are expected to expire between 2027 and 2042, subject to our payment of applicable maintenance fees and annuities.
The expiration dates described above may not account for all potentially available patent term adjustments and are subject to our payment of applicable issue fees, maintenance fees and annuities.
6 unchanged sentences
A provisional patent application is not eligible to become an issued patent until, among other things, we file a non-provisional patent application within 12 months of the filing date of the provisional patent application.
−Removed: If we do not timely file non-provisional patent applications, we may lose our priority date with respect to our provisional patent applications and any patent protection on the inventions disclosed in our provisional patent applications.
+Added: If we do not timely file non-provisional patent applications, we may lose our priority date with respect to our provisional patent applications and any patent protection on the inventions disclosed in our provisional patent
+Added: applications.
In the United States, patent term adjustments may be available depending upon the time the United States Patent and Trademark Office takes to examine and eventually issue a patent, and the patent term may be shorter than 20 years if we disclaim a portion of the patent term to overcome double patenting rejections.
1 unchanged sentence
In addition, we must generally pay fees to maintain our patents annually or at other specified intervals, or risk the patent lapsing.
−Removed: We cannot provide any assurance that any of our current or future owned or licensed patent applications will result in the issuance of patents in any jurisdiction, or that any of
−Removed: our current or future owned or licensed issued patents will effectively protect any of our products or technology or prevent others from commercializing competitive products or technology.
+Added: We cannot provide any assurance that any of our current or future owned or licensed patent applications will result in the issuance of patents in any jurisdiction, or that any of our current or future owned or licensed issued patents will effectively protect any of our products or technology or prevent others from commercializing competitive products or technology.
Even if any of our current or future owned or licensed patent applications are granted as issued patents, those patents may be challenged, circumvented or invalidated by third parties.
−Removed: We recently faced an opposition from anonymous challengers against one of our in-licensed European patents.
+Added: We previously faced an opposition from anonymous challengers against one of our in-licensed European patents.
The patent does not relate to aspects of Galleri or our precision oncology portfolio.
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The challengers have filed an appeal, which is currently pending.
−Removed: An additional opposition was filed on another of our in-licensed European patents relating to Galleri by an anonymous opponent, and this opposition is currently pending.
+Added: Two additional oppositions have been recently filed by anonymous opponents in connection with another two of our in-licensed European patents relating to Galleri, and these oppositions are currently pending.
While we believe that these patents are valid, there is a risk that these patents could be invalidated in their entirety, or certain claims of these patents could be amended and narrowed in scope.
License Agreements with the Chinese University of Hong Kong
−Removed: We have entered into five license agreements with the Chinese University of Hong Kong, each on substantially similar terms and with two dated April 7, 2016 and three dated May 29, 2017.
+Added: We have entered into five lic ense agreements with the Chinese University of Hong Kong, each on substantially similar terms and with two dated April 7, 2016 and three dated May 29, 2017.
Pursuant to these agreements, the Chinese University of Hong Kong has granted exclusive, worldwide intellectual property licenses to us for the use of certain nucleic acid sequencing and analysis technologies in all fields under one license and in all fields except prenatal diagnostics, prognostications, or analysis under four licenses.
1 unchanged sentence
Three of the licenses are subject to certain non-exclusive license rights granted by the Chinese University of Hong Kong to a certain third party, solely for such third party’s internal research purposes in the field of cancer detection, cancer prognostication and other analysis for the screening and management of cancer.
+Added: We have also entered into certain additional licenses with the Chinese University of Hong Kong on substantially similar terms covering additional patents.
To the extent our products use the licensed technology, such as our current Galleri and precision oncology products, we are required to pay the Chinese University of Hong Kong low single-digit percentage royalties on net sales of such products, subject to minimum annual guarantees, which began in 2018.
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We also rely on trade secret protection for our confidential and proprietary information.
−Removed: Included in our trade secrets are the data from our genomics studies, various aspects of the operation of our laboratories, and various aspects of the algorithms used to process our data.
+Added: Included in our trade secrets are various aspects of the operation of our assay and laboratories, and various aspects of the algorithms used to process our data.
Trade secrets are difficult to protect.
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For further discussion of the risks relating to our intellectual property, see “Risk Factors—Risks Relating to Intellectual Property.”
−Removed: Our principal office and laboratory is approximately 74,300 square feet and located at 1525 O’Brien Drive, Menlo Park, California.
−Removed: We amended the related lease in June 2017 to add approximately 57,400 square feet at 1605 Adams Drive, Menlo Park, California.
−Removed: Our lease expires in 2026 and we have an option to extend the lease for an additional five years.
−Removed: In June 2020, we entered into an agreement to lease approximately 200,000 square feet of a building in Durham, North Carolina.
−Removed: Our lease expires in 2033 and we have three separate options to extend the lease, each for an additional five years.
−Removed: We hold a CLIA Certificate of Accreditation Registration from the CMS and an accreditation from CAP for our laboratory in Durham, North Carolina.
−Removed: We also hold a Clinical Laboratory Certificate of Deemed Status from the State of California Department of Public Health.
−Removed: We believe that our facilities are sufficient to meet our current and anticipated near-term needs.
+Added: Seasonal fluctuations and underlying business trends have also affected, and are likely to continue to affect, our business.
+Added: We may experience this seasonality, in particular in the third quarter due to primary care physician and patient summer vacation periods, with relatively lower volume in the first and third quarters, and relatively higher volume in the second and fourth quarters.
+Added: These seasonal trends have caused, and will likely continue to cause, fluctuations in our quarterly results, including fluctuations in sequential revenue growth rates.
Human Capital
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We recognize that our employees are key to our ability to achieve this mission and believe our employees have been and will continue to be a primary reason for our growth and success.
−Removed: Recognizing the importance of our human capital, our board of directors retains direct oversight of our human capital and oversees and reviews our culture, policies, and strategies related to human capital management, including recruitment, development, performance management, rewards and employee engagement.
+Added: Recognizing the importance of our human capital, our board of directors retains oversight and reviews strategies related to human capital management, including compensation, rewards and employee engagement.
Employee Base
−Removed: Our workforce consists of a highly skilled, diverse, and engaged team dedicated to the company’s mission and goals.
+Added: Our workforce consists of a highly skilled and engaged team dedicated to the company’s mission and goals.
As of December 31, 2025, we had approximately 910 full-time employees.
−Removed: The majority of our employees are based in the United States at our sites in Menlo Park, California, Durham, North Carolina, and Washington D.C.
−Removed: We also engage with contractors, vendors, and consultants.
+Added: The majority of our employees are based in the United States at our sites in Menlo Park, California, Durham, North Carolina, and Washington D.C., along with our commercial team and other remote employees located throughout the US.
+Added: We also have an office in London, UK.
None of our employees are represented by a labor union or covered by a collective bargaining agreement.
We consider our relationship with our employees to be good.
+Added: Additionally, we engage with contractors, vendors, and consultants.
We are led by a multidisciplinary team with extensive experience across biotechnology, life sciences, public health, genomics, computer science, data science, biostatistics, clinical development, medical affairs, government and regulatory affairs, quality assurance, and laboratory and commercial operations.
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We are committed to fostering a workplace where all employees feel valued, supported, and empowered to contribute.
−Removed: We believe that diverse perspectives drive innovation and strengthen our ability to achieve our mission.
−Removed: Our culture is built on collaboration, respect, and continuous learning to ensure all team members can thrive.
+Added: We believe that varying perspectives drive innovation and strengthen our ability to achieve our mission.
+Added: Our culture is built on collaboration, respect, and continuous learning, ensuring that all team members can thrive.
We strongly believe our corporate culture is the operating system that powers the company and helps to achieve our mission.
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We’re open-minded, curious, and always learning.
−Removed: These values are the cornerstone of our leadership attributes and how we show up with one another and our customers.
+Added: These values are the cornerstone of our corporate culture, shaping how we interact with one another and our customers.
These values are embedded in our recruiting practices, performance management and reward programs.
Compensating and Supporting Our Colleagues
−Removed: We are committed to providing equitable compensation opportunities to attract and retain accountable, team-oriented, high-performing colleagues with the purpose of driving our mission.
−Removed: We consider external market data as well as internal parity considerations when making compensation decisions using data-informed actions to build desirable programs.
−Removed: To incentivize top performance, we aim to differentiate pay increases and incentive programs in recognition of colleague contributions aligned to the success of the business.
−Removed: We take a holistic approach to supporting employee well-being through providing eligible colleagues and their eligible dependents with competitive health and wellness benefits, retirement savings plans, and work-life options designed to provide flexibility to thrive.
−Removed: We also provide flexible time off and other opportunities to enable balance.
+Added: We are committed to providing equitable compensation opportunities to attract and retain accountable, team-oriented, high-performing colleagues, with the goal of advancing our mission.
+Added: We consider both external market data and internal parity considerations when making compensation decisions, using data-informed actions to build competitive programs.
+Added: To incentivize top performance, we aim to differentiate pay increases and incentive awards in recognition of colleague contributions aligned to the success of the business.
+Added: We take a holistic approach to supporting employee well-being by providing eligible colleagues and their eligible dependents with competitive health and wellness benefits, retirement savings plans, and work-life options designed to promote flexibility and support their overall well-being.
+Added: We also offer paid time off and other benefits to support a healthy work-life harmony.
Commitment to Learning and Development
3 unchanged sentences
Employees have access to a wide variety of online training programs, individual coaching programs for selected leaders, and mentoring programs.
−Removed: In addition, we offer leadership training through our LEAD program, which aims to build strong leaders who inspire our teams to achieve our corporate goals.
+Added: In addition, we offer leadership training, designed to build strong leaders who inspire our teams to achieve our corporate goals.
Government Regulations
3 unchanged sentences
Clinical laboratory tests are regulated under CLIA, as well as by applicable state laws.
−Removed: addition, the Federal Food, Drug and Cosmetic Act (“FDC Act”) defines a medical device to include any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man or other animals.
+Added: In addition, the Federal Food, Drug and Cosmetic Act (“FDC Act”) defines a medical device to include any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man or other animals.
The tests we are developing and marketing are considered by the FDA to be subject to regulation as medical devices.
Among other things, pursuant to the FDC Act and its implementing regulations, the FDA regulates the research, testing, manufacturing, safety, labeling, storage, recordkeeping, premarket clearance or approval, marketing and promotion, and sales and distribution of medical devices in the United States to ensure that medical products distributed domestically are safe and effective for their intended uses.
−Removed: The FDA has statutory authority to assure that medical devices are safe and effective for their intended uses, but the FDA has historically exercised its enforcement discretion and not enforced certain applicable provisions of the FDC Act and regulations with respect to LDTs.
−Removed: However, the FDA recently issued a final rule amending the FDA's regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the FDC Act, including when the manufacturer of the IVD is a laboratory, and phasing out its enforcement discretion with respect to LDTs.
−Removed: The final rule was effective as of July 5, 2024 and the phaseout policy is set to be implemented on May 6, 2025.
+Added: The FDA has statutory authority to assure that medical devices are safe and effective for their intended uses, but the FDA had historically exercised enforcement discretion and not enforced certain potentially applicable provisions of the FDC Act and regulations with respect to LDTs.
+Added: However, following the FDA’s September 2025 withdrawal of a final rule that intended to make explicit that in vitro diagnostic products are devices under the FDC Act, including when the manufacturer of the IVD is a laboratory, the scope of FDA’s authority to regulate LDTs remains unclear.
Clinical Laboratory Improvement Amendments of 1988 (CLIA)
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Under CLIA, a survey is generally conducted every two years by CMS, a CMS agent (typically a state agency), or, if the laboratory holds a CLIA Certificate of Accreditation, a CMS-approved accreditation organization (for example, CAP).
−Removed: The routine biennial survey includes review of the laboratory’s analytical validation of any LDTs performed by the laboratory.
+Added: The routine biennial survey includes a review of the laboratory’s analytical validation of any LDTs performed by the laboratory.
Penalties for non-compliance with CLIA requirements include a range of enforcement actions, including suspension, limitation or revocation of the laboratory’s CLIA certificate, as well as directed plan of correction, state on-site monitoring, civil monetary penalties, civil injunctive suit or criminal penalties.
CLIA provides that a state may adopt laboratory regulations that are more stringent than those under federal law, and a number of states have implemented their own more stringent laboratory regulatory requirements.
−Removed: State laws may require that laboratory personnel meet certain qualifications and obtain licenses, specify certain quality
−Removed: control procedures and facility requirements, or prescribe record maintenance requirements.
+Added: State laws may require that laboratory personnel meet certain qualifications and obtain licenses, specify certain quality control procedures and facility requirements, or prescribe record maintenance requirements.
For more information on state licensing and other requirements, see “—State Licensing Laws.”
5 unchanged sentences
Moreover, certain states, such as New York, require state approval of certain tests, including certain tests that have not been cleared or approved by the FDA (such as LDTs), through a premarket submission containing, among other information, documentation relating to device analytical and clinical performance data.
−Removed: The New York State Department of Health also mandates proficiency testing for laboratories granted a permit under New York State law, regardless of whether or not such laboratories are located in New York.
−Removed: We have obtained New York State Department of Health Clinical Laboratory Evaluation Program (NYSDOH CLEP) conditional approval for the updated commercial version of our Galleri launched in the fourth quarter of 2024.
+Added: NYSDoH also mandates proficiency testing for laboratories granted a permit under New York State law, regardless of whether or not such laboratories are located in New York.
+Added: We have obtained NYSDoH Clinical Laboratory Evaluation Program (NYSDOH CLEP) approval for the updated commercial version of our Galleri launched in the fourth quarter of 2024.
Clinical laboratory licensing laws in certain states, however, do not apply to laboratories operated for research purposes that do not return patient-specific results for the purpose of diagnosis or treatment.
9 unchanged sentences
Laboratory Developed Tests
−Removed: Under the FDA’s regulatory framework, in vitro diagnostic devices (“IVDs”), such as Galleri, are a type of medical device, including tests that can be used in the diagnosis or detection of diseases, such as cancer, or other conditions.
−Removed: The FDA considers LDTs to be a subset of IVDs that are intended for clinical use and are designed, manufactured, and used within a single laboratory.
−Removed: Although the FDA has statutory authority to assure that medical devices, including IVDs, are safe and effective for their intended uses, the FDA has historically exercised its enforcement discretion and not enforced certain applicable provisions of the FDC Act and regulations with respect to LDTs, with certain exceptions such as in the case of tests for public health emergencies or where the tests are offered directly to the consumer.
−Removed: Even under its current enforcement discretion policy, the FDA has issued warning letters to and safety communications about in vitro diagnostic device manufacturers for commercializing laboratory tests that were purported to be LDTs but that the FDA alleged failed to meet the definition of an LDT or otherwise were not subject to the FDA’s enforcement discretion policy.
−Removed: The FDA has for a number of years stated its intention to modify its enforcement discretion policy with respect to LDTs and impose applicable medical device requirements to LDTs more broadly.
−Removed: Most recently, the FDA proposed an amendment to its regulations in October 2023 that was finalized in May 2024, and became effective on July 5, 2024.
−Removed: This final rule clarifies the FDA’s historical view that LDTs are medical devices subject to the requirements applicable to other IVDs, and the FDA plans to phase in the enforcement of medical device requirements to LDTs over a period of four years.
−Removed: In connection with the final rule, the FDA established certain new, targeted enforcement discretion policies, including, among others, for LDTs marketed as of the date of publication of the final rule (May 6, 2024), as well as for LDTs that have received approval from New York State’s Clinical Laboratory Evaluation Program (“NY CLEP”).
−Removed: Specifically, the FDA intends to exercise enforcement discretion and not enforce certain medical device requirements (including the requirements for marketing authorization and compliance with certain elements of the Quality System Regulation (“QSR”)) with respect to LDTs that were marketed as of the date of the final rule’s publication, although such products must still comply with certain other FDA requirements, including registration and listing, portions of the QSR, medical device reporting, labeling, and corrections and removals reporting.
−Removed: However, where these tests are modified in certain ways from the version of the test marketed as of the final rule’s publication date, this enforcement discretion policy will no longer apply and the FDA intends to enforce all applicable FDA requirements (including premarket review and marketing authorization requirements) consistent with the phase-in policy.
−Removed: In addition, for LDTs that receive approval from NY CLEP, FDA intends not to enforce marketing authorization requirements when these requirements are phased in more generally at either three and a half or four years following the date of publication of the final rule.
−Removed: However, these tests will still be subject to the remaining medical device requirements, including registration and listing, medical device reporting, and quality system requirements, at the time that such requirements are phased in more generally.
−Removed: In addition to the FDA’s final rule, Congress has, for over the past decade, considered a number of proposals, which if enacted, would subject LDTs to additional regulatory requirements.
−Removed: Depending on the approach adopted under any potential legislation, certain LDTs (likely those of higher risk) may be required to undergo some form of premarket review of LDTs as IVCTs, potentially with a transition period for compliance and a grandfathering provision.
+Added: Under the FDA’s regulatory framework, in vitro diagnostic devices (“IVDs”), such as Galleri, are a type of medical device, including tests, which can be used in the diagnosis or detection of diseases, such as cancer, or other conditions.
+Added: The FDA has historically considered LDTs to be a subset of IVDs that are intended for clinical use and are designed, manufactured, and used within a single laboratory.
+Added: Although the FDA has statutory authority to assure that medical devices, including IVDs, are safe and effective for their intended uses, until recently the FDA had historically exercised its enforcement discretion pursuant to which it did not seek to enforce certain otherwise potentially applicable provisions of the FDC Act and regulations with respect to LDTs, with certain exceptions.
+Added: Even under that enforcement discretion policy, the FDA has issued warning letters to and safety communications about in vitro diagnostic device manufacturers for commercializing laboratory tests that were purported to be LDTs but that the FDA alleged failed to meet the definition of an LDT or otherwise were not subject to the FDA’s prior enforcement discretion policy.
+Added: The FDA had, for a number of years, stated its intention to modify this historical enforcement discretion policy with respect to LDTs and impose applicable medical device requirements to LDTs more broadly.
+Added: Recently, the FDA issued a final rule in an effort to clarify the FDA’s historical view that LDTs are medical devices subject to the requirements applicable to other IVDs.
+Added: However, on March 31, 2025, the United States District Court for the Eastern District of Texas vacated this final rule and remanded the matter to the FDA for further consideration.
+Added: The FDA did not appeal the ruling within the required timeline, and in September 2025, the FDA officially rescinded this final rule.
+Added: Accordingly, it remains uncertain whether or when the FDA may be able to exercise medical device authority with respect to these tests, including any LDTs for which a sponsor may plan to obtain a PMA.
+Added: In addition, Congress has, for over the past decade, considered a number of proposals, which if enacted, could subject LDTs to additional regulatory requirements.
+Added: As a result, the FDA’s oversight with respect to LDT products remains subject to significant uncertainty.
The FDA categorizes medical devices into one of three classes—class I, II, or III—based on the risks presented by the device and the regulatory controls necessary to provide a reasonable assurance of the device’s safety and effectiveness.
−Removed: Class I includes devices with the lowest risk to the patient and are those for which safety and effectiveness can be assured by adherence to the FDA’s General Controls for medical devices, which include compliance with the applicable portions of the QSR facility registration and product listing, reporting of adverse medical events, and truthful and non-misleading labeling, advertising, and promotional materials.
+Added: Class I includes devices with the lowest risk to the patient and are those for which safety and effectiveness can be assured by adherence to the FDA’s General Controls for medical devices, which include compliance with the applicable portions of the Quality Management System Regulation (“QMSR”) facility registration and product listing, reporting of adverse medical events, and truthful and non-misleading labeling, advertising, and promotional materials.
Class II devices are subject to the FDA’s General Controls, and special controls as deemed necessary by the FDA to ensure the safety and effectiveness of the device.
7 unchanged sentences
Obtaining PMA approval requires the submission of “valid scientific evidence” to the FDA to support a finding of a reasonable assurance of the safety and effectiveness of the device.
−Removed: A PMA must provide complete analytical and clinical performance data
−Removed: and also information about the device and its components regarding, among other things, device design, manufacturing, and labeling.
+Added: A PMA must provide complete analytical and clinical performance data and also information about the device and its components regarding, among other things, device design, manufacturing, and labeling.
Following receipt of a PMA, the FDA determines whether the application is sufficiently complete to permit a substantive review.
2 unchanged sentences
The FDA may or may not accept the panel’s recommendation.
−Removed: As part of the FDA’s review of a PMA, the FDA will typically inspect the manufacturer’s facilities for compliance with QSR requirements, which impose requirements related to design controls, manufacturing controls, documentation, and other quality assurance procedures.
+Added: As part of the FDA’s review of a PMA, the FDA will typically inspect the manufacturer’s facilities for compliance with QMSR requirements, which impose requirements related to design controls, manufacturing controls, documentation, and other quality assurance procedures.
The user fee costs and the length of the FDA review time for obtaining PMA approval are significantly higher than for a 510(k) notification or a de novo classification.
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If an IDE application is approved by the FDA and one or more IRBs, human clinical trials may begin at a specific number of investigational sites with a specific number of patients, as approved by the FDA.
−Removed: If the device presents a non-significant risk to the patient, a sponsor may begin
−Removed: the clinical trial after obtaining approval for the trial by one or more IRBs without separate approval from the FDA, but must still follow abbreviated IDE requirements, such as monitoring the investigation, ensuring that the investigators obtain informed consent, and labeling and record-keeping requirements.
+Added: If the device presents a non-significant risk to the patient, a sponsor may begin the clinical trial after obtaining approval for the trial by one or more IRBs without separate approval from the FDA, but must still follow abbreviated IDE requirements, such as monitoring the investigation, ensuring that the investigators obtain informed consent, and labeling and record-keeping requirements.
Acceptance of an IDE application for review does not guarantee that the FDA will allow the IDE to become effective and, if it does become effective, the FDA may or may not determine that the data derived from the trials support the safety and effectiveness of the device or warrant the continuation of clinical trials.
11 unchanged sentences
• establishment registration and device listing with the FDA;
−Removed: • QSR requirements, which currently require manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all aspects of the design and manufacturing process;
+Added: • QMSR requirements, which require manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all aspects of the design and manufacturing process;
• labeling regulations and FDA prohibitions against the promotion of “off-label” uses of cleared or approved products;
6 unchanged sentences
• post-market surveillance activities and regulations, which apply when deemed by the FDA to be necessary to protect the public health or to provide additional safety and effectiveness data for the device.
−Removed: Device manufacturing processes subject to FDA oversight are required to comply with the applicable portions of the QSR, which currently cover the methods and the facilities and controls for the design, manufacture, testing, production, processes, controls, quality assurance, labeling, packaging, distribution, installation, and servicing of finished devices intended for human use.
−Removed: The QSR also requires, among other things, maintenance of a device master file, device history file, and complaint files.
+Added: Device manufacturing processes subject to FDA oversight are required to comply with the applicable portions of the QMSR, which cover the methods and the facilities and controls for the design, manufacture, testing, production, processes, controls, quality assurance, labeling, packaging, distribution, installation, and servicing of finished devices intended for human use.
+Added: The QMSR also requires, among other things, maintenance of a medical device file and complaint files.
Manufacturers are subject to periodic scheduled or unscheduled inspections by the FDA.
−Removed: A failure to maintain compliance with the QSR requirements could result in the shut-down of, or restrictions on, manufacturing operations and the recall or seizure of products.
+Added: A failure to maintain compliance with the QMSR requirements could result in the shut-down of, or restrictions on, manufacturing operations and the recall or seizure of products.
The discovery of previously unknown problems with products, including unanticipated adverse events or adverse events of increasing severity or frequency, whether resulting from the use of the device within the scope of its approval or off-label by a physician in the practice of medicine, could result in restrictions on the device, including the removal of the product from the market or voluntary or mandatory device recalls.
12 unchanged sentences
The Stark Law generally prohibits us from billing, presenting, or causing to be presented a claim for any clinical laboratory services or other designated health services payable by the Medicare or Medicaid programs when the physician ordering the service, or any member of such physician’s immediate family, has an ownership interest in, or compensation arrangement with, us, unless the arrangement meets an exception to the prohibition.
−Removed: The Stark Law contains several exceptions, including an exception for compensation paid to a physician for personal services rendered by the physician provided that several conditions are met, including that the payment is set at fair market value for the services furnished and the terms of the arrangement be set out in writing and signed by the parties.
+Added: The Stark Law contains several exceptions, including an exception for compensation paid to a physician for personal services rendered by the physician provided that several conditions are met, including that the payment is set at fair market value for the services furnished and the terms of the arrangement are set out in writing and signed by the parties.
These prohibitions apply regardless of the reasons for the financial relationship and the referral.
27 unchanged sentences
Federal and state law enforcement authorities scrutinize arrangements between healthcare providers and potential referral sources to ensure that the arrangements are not designed as a mechanism to induce healthcare referrals or induce the purchase, prescribing or ordering of particular products or services.
−Removed: Law enforcement authorities and the courts have also demonstrated a willingness to look behind the formalities of a transaction to determine the underlying purpose of any remuneration exchanged between healthcare providers and actual or
−Removed: potential referral sources.
+Added: Law enforcement authorities and the courts have also demonstrated a willingness to look behind the formalities of a transaction to determine the underlying purpose of any remuneration exchanged between healthcare providers and actual or potential referral sources.
Generally, courts have taken a broad interpretation of the scope of the Anti-Kickback Statute, holding that the statute may be violated if merely one purpose of a payment arrangement is to induce referrals or purchases.
25 unchanged sentences
The Sunshine Act was enacted by Congress in 2010 as part of the Affordable Care Act (“ACA”) and was amended in 2018 by the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act.
−Removed: The Sunshine Act requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to report annually to CMS certain data on payments and other transfers of
−Removed: value made to U.S.-licensed physicians (as defined by statute), teaching hospitals, and certain non-physician practitioners, including physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, anesthesiologist assistants and certified nurse-midwives.
+Added: The Sunshine Act requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to report annually to CMS certain data on payments and other transfers of value made to U.S.-licensed physicians (as defined by statute), teaching hospitals, and certain non-physician practitioners, including physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, anesthesiologist assistants and certified nurse-midwives.
The data are sent to CMS for public disclosure on the Open Payments.
26 unchanged sentences
As a general rule, demonstration of conformity of IVDs and their manufacturers with the essential requirements must be based, among other things, on the evaluation of clinical data supporting the safety and performance of the products during normal conditions of use.
−Removed: Specifically, a manufacturer must demonstrate that the device achieves its intended performance during normal conditions of use, that the known and foreseeable risks, and any adverse events, are minimized and acceptable when weighed against the benefits of its intended
−Removed: performance, and that any claims made about the performance and safety of the device are supported by suitable evidence.
+Added: Specifically, a manufacturer must demonstrate that the device achieves its intended performance during normal conditions of use, that the known and foreseeable risks, and any adverse events, are minimized and acceptable when weighed against the benefits of its intended performance, and that any claims made about the performance and safety of the device are supported by suitable evidence.
In Vitro Diagnostic Medical Devices Regulation
25 unchanged sentences
Since January 1, 2021, the Medicines and Healthcare Products Regulatory Agency (“MHRA”) has become the sovereign regulatory authority responsible for Great Britain.
−Removed: All IVDs are required to be registered with the
−Removed: MHRA, and since January 1, 2022, manufacturers based outside the UK have been required to appoint a UK responsible person that has a registered place of business in the UK to register devices with the MHRA.
−Removed: Under the powers granted by the Medicines and Medical Devices Act 2021, on December 16, 2024, the UK government published an amendment to the UK MDR to clarify and strengthen the post-market surveillance (PMS) requirements for medical devices in Great Britain.
−Removed: This amendment will come into force on June, 16 2025 and aims to facilitate greater traceability of incidents and trends enabling the MHRA to act swiftly when needed to address safety issues and support the entire health system in better protecting patients.
+Added: All IVDs are required to be registered with the MHRA, and since January 1, 2022, manufacturers based outside the UK have been required to appoint a UK responsible person that has a registered place of business in the UK to register devices with the MHRA.
+Added: Under the powers granted by the Medicines and Medical Devices Act 2021, on December 16, 2024, the UK government passed an amendment to the UK MDR to clarify and strengthen the post-market surveillance requirements for medical devices in Great Britain.
+Added: This amendment became applicable on June, 16 2025 and aims to facilitate greater traceability of incidents and trends enabling the MHRA to act swiftly when needed to address safety issues and support the entire health system in better protecting patients.
In addition, the MHRA launched a consultation from November 14, 2024 to January 5, 2025 on proposed changes to the pre-market requirements for medical devices in Great Britain.
−Removed: The MHRA has stated that it will incorporate feedback to this consultation in drafting new UK legislation on pre-market requirements for medical devices in Great Britain.
−Removed: The new legislation is expected to be implemented in 2026 and aims to enable greater international collaboration and practices, with more patient-centered, proportionate requirements for medical devices which are responsive to technological advances.
+Added: On July 22, 2025, the MHRA published a response to the consultation confirming that it will incorporate feedback to this consultation in drafting new UK legislation on pre-market requirements for medical devices in Great Britain.
+Added: A draft of the new legislation is expected to be published in 2026 and aims to enable greater international collaboration and practices, with more patient-centered, proportionate requirements for medical devices which are responsive to technological advances.
Under the UK MDR, in order to be lawfully placed on the Great Britain market, class A (non-sterile) IVDs need to be “UKCA” self certified, and other IVDs need to be “UKCA” certified by a UK approved body.
−Removed: However, certain IVDs in compliance with either the EU IVDD or IVDR can continue to be placed on the Great Britain market until the sooner of certificate expiration or June 30, 2030.
+Added: However, certain IVDs in compliance with (a) the EU IVDD can continue to be placed on the Great Britain market until the sooner of certificate expiration or June 30, 2030;
+Added: and (b) the EU IVDR can continue to be placed on the Great Britain market until June 30, 2030.
Coverage and Reimbursement
−Removed: We are pursuing payment for our products through a diverse and broad range of channels, including sales to self-insured employers, integrated health systems, healthcare providers, life insurance companies, and patients, as well as, where available, through coverage and reimbursement by government healthcare programs and commercial third-party payors.
+Added: We are pursuing payment for our products through a diverse and broad range of channels, including sales to integrated health systems, self-insured employers, digital health platforms, healthcare providers, life insurance companies, and patients, as well as, where available, through coverage and reimbursement by government healthcare programs and commercial third-party payors.
United States
8 unchanged sentences
Generally, Medicare will not cover screening tests, which are considered preventive services, that are performed in the absence of signs or symptoms of illness or injury, except if explicitly authorized by statute.
−Removed: CMS, the agency responsible for administering the Medicare program, authorizes certain additional preventive services including certain screening tests that are not expressly covered by statute if the service is (a) reasonable and necessary for the prevention or early detection of an illness or disability, (b) recommended with a grade of A or B by the USPSTF, an independent, volunteer panel of experts in the field of prevention, evidence-based medicine and primary care, and (c) appropriate for Medicare beneficiaries under Part A or Part B.
+Added: In February 2026, the Nancy Gardner Sewell Medicare MCED Coverage Act became law and created a statutory Medicare coverage benefit category for multi-cancer early detection tests.
+Added: The law included certain standards, including that CMS, the agency responsible for administering the Medicare program, would establish coverage through a national coverage determination (“NCD”) process under “reasonable and necessary” evidentiary requirements.
+Added: An NCD typically involves a multi-step review that can include evidence assessment by CMS staff, consultation with external technology assessment organizations, a Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) meeting, and opportunities for public comment.
+Added: Medicare may issue an NCD to provide coverage for MCED tests that are cleared under 510(k), classified under 513(f)(2) or approved by the FDA, with authority to initiate coverage as early as January 1, 2029, although any NCD may be delayed or be more restrictive than the full authority provided by statute.
+Added: Coverage eligibility is phased in, with those aged 50-65 eligible under the law in 2029, expanding by one age-year annually.
+Added: We are seeking FDA approval for Galleri, and in January 2026, we submitted a PMA to the FDA.
+Added: If we receive FDA approval for Galleri, Galleri would be eligible for coverage under this new statute, subject to the NCD by CMS.
+Added: Nonetheless, no version of Galleri has been approved or cleared by the FDA and obtaining PMA approval can take several years, if at all, from the time the PMA was submitted.
+Added: Galleri may not be approved on our expected timeline or at all.
+Added: Beyond this new statute, CMS authorizes certain additional preventive services including certain screening tests that are not expressly covered by statute if the service is (a) reasonable and necessary for the prevention or early detection of an illness or disability, (b) recommended with a grade of A or B by the USPSTF, an independent, volunteer panel of experts in the field of prevention, evidence-based medicine and primary care, and (c) appropriate for Medicare beneficiaries under Part A or Part B.
CMS establishes coverage through an NCD process.
1 unchanged sentence
In its discretion, the USPSTF generally waits for FDA authorization before it considers undertaking review of novel technology.
−Removed: Galleri could be considered a screening test under Medicare and, accordingly, is unlikely to be covered by Medicare without pursuing the CMS NCD-related measures described above.
+Added: Galleri could be considered a screening test under Medicare and, accordingly, is unlikely to be covered by Medicare without pursuing the CMS NCD-related measures described above for MCED tests or for other screening under additional preventative services.
These processes may take multiple years to complete as currently, coverage decisions for preventive services are not made prior to FDA authorization.
−Removed: Even if we pursue these processes, it is possible that Galleri will never become eligible for Medicare coverage and reimbursement.
−Removed: We are evaluating opportunities for nearer-term reimbursement through Medicare
−Removed: Advantage plans, while generating evidence to meet the requirements of the traditional Medicare path.
+Added: Even if we pursue these processes, it is possible that Galleri will never become eligible for Medicare coverage and reimbursement, and under the new MCED coverage benefit category, the coverage would only apply to a relatively small portion of the overall Medicare population due to the age restriction and annual phase in requirement.
+Added: Accordingly, we expect to pursue inclusion in the USPSTF guidelines even if we receive initial coverage under the new statute to enable a broader CMS NCD.
+Added: We are evaluating opportunities for nearer-term reimbursement through Medicare Advantage plans, while generating evidence to meet the requirements of the traditional Medicare path.
Medicare Advantage plans generally must cover all of the services that traditional Medicare covers (except hospice care), but they have the discretion to offer their enrollees additional, or supplemental, benefits not otherwise covered under traditional Medicare, including those benefits referred to as optional supplemental benefits, for which enrollees may elect to pay extra to receive coverage.
13 unchanged sentences
CMS uses the data reported, which includes certain private payor payment rates for each test the laboratory performs, the volume of tests paid at each rate, and the HCPCS code associated with the test, to calculate a weighted median payment rate for each test, which is used to establish revised Medicare CLFS reimbursement rates for clinical diagnostic laboratory tests (“CDLTs”).
−Removed: If the test is an advanced diagnostic laboratory test (“ADLT”), the test will be paid based on an actual list charge for an initial period of three quarters before being shifted to the weighted median private payor rate reported by the laboratory performing the ADLT.
+Added: If the test is an advanced diagnostic laboratory test (“ADLT”), the test is paid based on an actual list charge for an initial period of three quarters before
+Added: being shifted to the weighted median private payor rate reported by the laboratory performing the ADLT.
Laboratories offering ADLTs are subject to recoupment if the actual list charge exceeds the weighted median private payor rate by a certain amount.
1 unchanged sentence
The revised reimbursement methodology described above generally results in relatively lower reimbursement amounts under Medicare for clinical laboratory services than has been historically reimbursed.
−Removed: Any reductions to reimbursement rates resulting from the new methodology are limited to 0% in 2023 and 15% per test per year in each of 2024 through 2026.
+Added: Any reductions to reimbursement rates resulting from the new methodology are limited to 0% through January 30, 2026 and 15% per test per year from January 31, of 2026 through 2028.
In addition, PAMA codified Medicare coverage rules for laboratory tests by requiring any local coverage determination to be made following the local coverage determination process.
31 unchanged sentences
Additionally, the American Taxpayer Relief Act of 2012, among other things, reduced CMS payments to several providers, including hospitals, and increased the statute of limitations period for the government to recover Medicare overpayments to providers from three to five years.
+Added: The One Big Beautiful Bill Act (the “OBBBA”) also included significant reforms to Medicaid, including an estimated $1 trillion in reduced federal Medicaid spending from 2025 through 2034, the imposition of work requirements for certain adult enrollees, more frequent eligibility redeterminations, and increased cost-sharing for beneficiaries.
+Added: These changes are expected to reduce overall Medicaid enrollment and access to care.
+Added: Although the effect on our business is currently unknown, any decrease in the number of insured patients or reimbursement levels for our tests could adversely affect our revenue and commercial prospects.
In the EU, on December 13, 2021, Regulation No 2021/2282 on Health Technology Assessment (“HTA”) amending Directive 2011/24/EU, was adopted.
6 unchanged sentences
Changes in healthcare policy could increase our costs, decrease our revenue and impact sales of and reimbursement for our products.
−Removed: Data Privacy and Security Regulation
−Removed: Data Privacy and Security Laws
−Removed: Numerous state, federal and foreign laws, regulations and standards govern the collection, use, access to, confidentiality and security of health-related and other personal information, and could apply now or in the future to our operations or the operations of our partners.
+Added: Data Privacy and Cybersecurity Regulation
+Added: Data Privacy and Cybersecurity Laws
+Added: Numerous state, federal and international laws, regulations and standards govern the collection, use, access to, disclosure, confidentiality and security of health-related and other personal information, and could apply now or in the future to our operations or the operations of our partners.
In the United States, numerous federal and state laws and regulations, including data breach notification laws, health information privacy and security laws and consumer protection laws and regulations govern the collection, use, disclosure, and protection of health-related and other personal information.
−Removed: In addition, certain foreign laws govern the privacy and security of personal data, including health-related data.
−Removed: Privacy and security laws, regulations, and other obligations are constantly evolving, may conflict with each other to complicate compliance efforts, and can result in investigations, proceedings, or actions that lead to significant civil and/or criminal penalties and restrictions on data processing.
−Removed: For additional information, see the section entitled “Risk Factors” beginning on page 37 of this Annual Report on Form 10-K.
+Added: In addition, certain international laws govern the privacy and security of personal data, including health-related data, including but not limited to the EU General Data Protection Regulation (“EU GDPR”) and UK General Data Protection Regulation (“UK GDPR”) (EU GDPR and UK GDPR, together, “GDPR”).
+Added: Privacy and security laws, regulations, and other obligations are constantly evolving, may conflict with each other to complicate compliance efforts, and failure to comply can result in investigations, proceedings, or actions that lead to significant civil and/or criminal penalties, restrictions on data processing and reputational damage.
+Added: For additional information, see Part I, Item 1A.
+Added: “Risk Factors” of this Annual Report on Form 10-K.
Illumina acquired the common stock of GRAIL that it did not own and completed its acquisition of GRAIL on August 18, 2021 (the “Acquisition”).
8 unchanged sentences
These agreements govern the relationship between Illumina and us after completion of the Spin-Off and allocated between Illumina and us various assets, liabilities and obligations, including those related to employees and compensation and benefits plans and programs and tax-related assets and liabilities.
−Removed: See Note 15 - Related Party Transactions in Item 8.
−Removed: Financial Statements of this Annual Report on Form 10-K for more information.
+Added: During the fourth quarter of 2025, Illumina sold 2,000,000 shares of the Company’s common stock reducing its ownership to 2,502,126 shares, which represented approximately 6.0% of the Company’s outstanding common stock as of December 31, 2025.
+Added: On February 17, 2026, Illumina filed a Schedule 13G reporting beneficial ownership of 1,302,126 shares of our common stock.
+Added: See Note 16 — Related Party Transactions for more information.
Other Information
2 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.