What changed in this filing

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Item 1. Business

2026-02-19 compared with 2025-02-20 · 126 added, 134 removed, 522 unchanged (33% of the section changed)

We are a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer.

We are transforming patient care by providing critical insights into what drives disease through our advanced blood and tissue tests and real-world data.

Our tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and helping doctors select the best treatment for patients with advanced cancer.

For patients with advanced-stage cancer, we have commercially launched Guardant360 laboratory developed test, or LDT, and Guardant360 CDx, the first comprehensive liquid biopsy test approved by the U.S.

Food and Drug Administration, or the FDA, to provide tumor mutation profiling with solid tumors and to be used as a companion diagnostic in connection with non-small cell lung cancer, or NSCLC, and breast cancer.

We have also launched the Guardant360 TissueNext tissue test for advanced-stage cancer, Guardant Reveal blood test to detect residual and recurring disease in early-stage colorectal, breast and lung cancer patients, and Guardant360 Response blood test to predict patient response to immunotherapy or targeted therapy eight weeks earlier than current standard-of-care imaging.

We also collaborate with biopharmaceutical companies in clinical studies by providing the above-mentioned tests, as well as the GuardantOMNI blood test for advanced-stage cancer, and the GuardantINFINITY blood test, a next-generation Smart Liquid Biopsy that provides new, multi-dimensional insights into the complexities of tumor molecular profiles and immune response to advance cancer research and therapy development.

Using data collected from our tests, we have also developed our GuardantINFORM platform to help biopharmaceutical companies accelerate precision oncology drug development through the use of this in-silico research platform to unlock further insights into tumor evolution and treatment resistance across various biomarker-driven cancers.

For early cancer detection, in May 2022, we launched the Shield LDT test to address the needs of individuals eligible for colorectal cancer screening.

From a simple blood draw, Shield uses a novel multimodal approach to detect colorectal cancer signals in the bloodstream, including DNA that is shed by tumors.

In December 2022, we announced that the ECLIPSE study, a registrational study evaluating the performance of our Shield blood test for detecting colorectal cancer in average-risk adults, met co-primary endpoints.

In addition, in March 2023, we submitted a premarket approval application, or PMA, for our Shield blood test to the FDA.

In July 2024, we received FDA approval of our Shield blood test for colorectal cancer screening in adults age 45 and older who are at average risk for the disease, and in August 2024, our Shield blood test became commercially available in the U.S.

as the first blood test approved by the FDA for primary colorectal cancer screening, meaning healthcare providers can offer Shield in a manner similar to all other non-invasive methods recommended in screening guidelines.

Shield is also the first blood test for colorectal cancer screening that meets coverage requirements by Medicare.

We also expect to expand into lung cancer screening and multi-cancer detection with our Shield platform.

We are transforming patient care by providing critical insights into what drives disease through our advanced blood and tissue tests, real-world data and AI analytics.

Our tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer.

For patients with advanced-stage cancer, we offer the Guardant360 Liquid test, formerly known as the Guardant360 LDT test, and the Guardant360 CDx test, the first comprehensive liquid biopsy test approved by the U.S.

We also offer the Guardant360 Tissue test for advanced-stage cancer and the Guardant Reveal test to detect residual and recurring disease in early-stage colorectal, breast and lung cancer patients.

We have also expanded the Guardant Reveal test to include late-stage therapy response monitoring for patients with solid tumors.

Our product portfolio is now powered by our Smart Platform, which utilizes methylation technology with genomic, epigenomic, and RNA-based data, to unlock multi-modal biology with proprietary chemistry, advanced algorithms and our InfinityAI learning engine.

We also collaborate with biopharmaceutical companies in clinical studies by providing the above-mentioned tests, as well as the GuardantINFINITY blood test, also powered by our Smart Platform, which provides new, multi-dimensional insights into the complexities of tumor molecular profiles and immune response to advance cancer research and therapy development, and the GuardantOMNI blood test for advanced-stage cancer.

Using data collected from our tests and through AI-enabled analytical tools, we have also developed our GuardantINFORM platform to help biopharmaceutical companies accelerate precision oncology drug development through the use of this in-silico research platform to unlock further insights into tumor evolution and treatment resistance across various biomarker-driven cancers.

For early cancer detection, we offer the Shield blood test for colorectal cancer screening in adults age 45 and older who are at average risk for the disease.

Shield is the first blood test approved by the FDA for primary colorectal cancer screening and also the first blood test for colorectal cancer screening that meets coverage requirements by Medicare.

In addition, our Shield blood test is included in the National Comprehensive Cancer Network colorectal cancer screening guidelines.

We also expect to expand into lung cancer screening and multi-cancer detection, or MCD, with our Shield platform.

The FDA has granted Breakthrough Device designation to our Shield MCD test to provide patients and healthcare providers with timely access to medical devices by speeding up their development, assessment and review.

In addition, we have expanded our Shield blood test to include an MCD results report with a data collection effort to better understand the clinical impact of MCD results.

Our objective is to be the leading provider of therapy selection, minimal residual disease detection, and early cancer screening products for cancer management across all stages of the disease and drive commercial adoption of our products.

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• Increase awareness of our products by:

▪ building awareness of liquid biopsy and pioneering a blood-first paradigm for genotyping cancer patients;

▪ building awareness of our product portfolio and developing both blood and tissue testing across all stages of care;

▪ employing screening awareness initiatives, including through direct-to-consumer channels, to support primary care clinician adoption, improve screening adherence and reach unscreened populations;

▪ educating biopharmaceutical companies, key opinion leaders, or KOLs, and advocacy groups;

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• Expand clinical utility and increase reimbursement for our products by:

▪ working with private and public payers to establish coverage and reimbursement for our tests;

▪ investing in clinical evidence directly and through relationships with academia and biopharmaceutical companies to establish expanded indications for use;

▪ working with commercial and government payers to establish coverage and reimbursement for our tests;

▪ investing in clinical and real-world evidence directly and through relationships with academia, biopharmaceutical companies and health systems to establish expanded indications for use;

▪ demonstrating improved clinical utility and health economics from use of our tests to patients, physicians and payers;

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▪ providing earlier insights into emerging clinically relevant biomarkers;

▪ providing seamless customer experiences through collaborations with electronic medical record partners;

▪ providing seamless customer experiences through collaborations with electronic medical record partners and expanded phlebotomy access;

▪ expanding lab capabilities and services through partnerships.

• Expand our product portfolio by:

▪ using our commercial engine as a force multiplier of returns on research and development investment to generate data and analytical insights to enable development of new products;

▪ taking a disciplined and systematic approach to product and market development for cancer management across all stages of the disease;

▪ using our commercial engine and research and our development investment to generate data and analytical insights to enable development of new products;

▪ taking a disciplined and systematic approach to product and market development for patient care across all stages of the disease;

▪ utilizing our data, sample biobank and insights into biology of circulating tumor-related biomarkers in blood to develop our new products;

▪ building on our regulatory and commercial infrastructure to accelerate new product launches and drive commercial efficiencies;

▪ using our strategic relationships, including our partnerships with cancer centers, research organizations and laboratory companies in Europe and Asia, to drive global commercialization of our products.

▪ using our strategic relationships, including our partnerships with cancer centers, research organizations, distributors and laboratory companies in Europe and Asia, to drive global commercialization of our products.

Our products and development program

We have launched various products and programs using our digital sequencing technology, which is enabled by robust, high-efficiency biochemistry at the front-end, next-generation sequencing and a machine learning augmented bioinformatics pipeline.

We believe our product portfolio could address the full continuum of cancer care for selected indications, and has utility in both the clinical and biopharmaceutical markets.

We have launched various products and programs and we believe our product portfolio could address the full continuum of patient care, and has utility in both the clinical and biopharmaceutical markets.

Therapy Selection

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Our Guardant360 CDx test is a 74-gene test to provide tumor mutation profiling to be used by qualified health professionals in accordance with professional guidelines in oncology for cancer patients with any solid malignant neoplasm.

Our Guardant360 CDx test has also been approved by the FDA for use as a companion diagnostic to identify NSCLC patients who may benefit from treatment with TAGRISSO® (osimertinib), RYBREVANT® (amivantamab-vjmw), LUMAKRAS™ (sotorasib) and ENHERTU® (fam-trastuzumab deruxtecan-nxki), and breast cancer patients who may benefit from treatment with ORSERDU™ (elacestrant), marketed by biopharmaceutical companies.

Our Guardant360 CDx test has also been approved by the FDA for use as a companion diagnostic to identify NSCLC patients who may benefit from treatment with TAGRISSO® (osimertinib), RYBREVANT® (amivantamab-vjmw), LUMAKRAS™ (sotorasib) and ENHERTU® (fam-trastuzumab deruxtecan-nxki), breast cancer patients who may benefit from treatment with ORSERDU™ (elacestrant) and INLURIYO™ (imlunestrant), and colorectal cancer patients who may benefit from treatment with BRAFTOVI® (encorafenib), marketed by biopharmaceutical companies.

Additional gene content and immune-oncology biomarkers (e.g.

microsatellite instability, or MSI) are reported in a professional services compendium to the FDA approved CDx report.

Results are typically delivered within seven days following receipt of sample and delivered by a clinical report.

Guardant360 LDT

Results are typically delivered within five days following receipt of sample and delivered by a clinical report.

Guardant360 Liquid Test (formerly known as Guardant360 LDT Test)

The number of personalized therapy options for advanced cancer patients continues to grow, giving patients who may have cycled through standard of care therapies additional options.

Our Guardant360 LDT test measures 730+ genes and supports all guideline-recommended biomarkers, to help inform which therapy may be effective for advanced stage cancer patients with solid tumors, without the need to obtain archival tissue or subject the patient to another invasive biopsy.

Our Guardant360 LDT test has been migrated to the Smart Liquid Biopsy platform which enables more sensitive epigenetic tumor fraction detection.

Our Guardant360 Liquid test measures 740+ genes and supports all guideline-recommended biomarkers, to help inform which therapy may be effective for advanced stage cancer patients with solid tumors, without the need to obtain archival tissue or subject the patient to another invasive biopsy.

We have also introduced new smart applications for our Guardant360 Liquid test that greatly expand its biomarker identification and cancer subtyping capabilities to help oncologists identify optimal treatment plans.

In addition, our Guardant360 Liquid test has been migrated to the Smart Platform which enables more sensitive genomic and epigenetic tumor fraction detection.

Results are typically delivered within seven days following receipt of sample and delivered by a clinical report.

Guardant360 Response Test

Our Guardant360 Response test is the first blood-only liquid biopsy that enables doctors to view molecular response, or changes in circulating tumor DNA, or ctDNA, levels, from a simple blood draw to potentially gain early insight regarding patient response to treatment.

For doctors, knowing early and confidently if a patient’s treatment is working is critical in deciding whether to continue, stop, or explore other options.

Studies across cancers and therapies show the Guardant360 Response test predicted treatment response eight weeks earlier than current standard-of-care radiological and imaging scans.

Guardant360 TissueNext Test

To complement our liquid biopsy-based products, Guardant360 TissueNext, our first tissue-based test with AI-powered PD-L1 detection, is designed to identify patients with advanced cancer who may benefit from biomarker-informed treatment.

Tissue genotyping is currently widely available to physicians and patients.

We believe many tissue genotyping products currently available to physicians and patients have experienced long delays in getting results to physicians and high failure rates because of the inability to obtain enough tissue or high-quality DNA for analysis.

Such delay or inability to produce results from tissue genotyping can adversely affect providing the right treatment to patients at the right time.

We therefore believe our Guardant360 TissueNext test, together with our liquid biopsy-based products, have the potential to help address the challenges with tissue genotyping products currently in the market.

Guardant Reveal Test

In addition to minimal residual disease (MRD) detection, we have expanded our Guardant Reveal test to include late-stage therapy response monitoring for patients with solid tumors.

Building on Guardant Reveal’s proven performance in MRD detection, the expanded offering leverages our proprietary epigenomic technology powered by the Smart Platform to predict therapy response across all therapy classes, including immunotherapy and chemotherapy, which most patients with advanced-stage cancer receive at some point during their treatment.

Guardant Reveal therapy response monitoring can be initiated at any time during a patient’s treatment journey, offering clinicians flexibility and actionable insights in just seven days.

Guardant360 Tissue Test

To complement our liquid biopsy-based products, we offer Guardant Tissue, the first molecular profiling test for tumor tissue that incorporates comprehensive multiomics analysis, including DNA, RNA, AI-powered PD-L1 and genome-wide methylation data, to provide researchers and cancer care teams with a more comprehensive view of cancer.

Powered by our Smart Platform, the Guardant360 Tissue test enables insights from comprehensive analysis of epigenetics that can apply to important classes of therapies in late-stage development and enables classification and subtyping of each individual tumor at a much higher resolution.

In addition, the Guardant360 Tissue test requires less tissue surface area for analysis than the industry norm, which allows biopharmaceutical researchers and healthcare providers to successfully analyze tissue samples with fewer slides and thus test more patients using less precious tissue.

Minimal Residual Disease Detection and Recurrence Monitoring

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We expect to address this need, first in early-stage colorectal, breast and lung cancers, with our Guardant Reveal tissue-free blood test for residual disease and recurrence monitoring.

We believe the Guardant Reveal test has the potential to enable oncologists to improve the care of early-stage cancer patients by correctly identifying more high-risk patients than clinicopathologic review alone and by detecting recurrent disease months earlier than current standard of care methods like imaging carcinoembryonic antigen tests.

We believe the Guardant Reveal test can improve turnaround by simultaneously interrogating both genomic and epigenomic signals from a single blood draw without the need for tissue.

In addition, our Guardant Reveal test has been migrated to the Smart Liquid Biopsy platform which could maximize detection sensitivity without requiring tissue.

We believe the Guardant Reveal test has the potential to enable oncologists to improve

the care of early-stage cancer patients by correctly identifying more high-risk patients than clinicopathologic review alone and by detecting recurrent disease months earlier than current standard of care methods like imaging carcinoembryonic antigen tests.

We believe the Guardant Reveal test can improve turnaround by interrogating epigenomic signals from a single blood draw without the need for tissue.

In addition, our Guardant Reveal test has been migrated to the Smart Platform which could maximize detection sensitivity without requiring tissue.

Similar to our data development effort for our Guardant360 tests, we are investing heavily in establishing clinical validity and utility for the use of Guardant Reveal in adjuvant treatment and surveillance settings.

We also believe our Guardant Reveal test may help biopharmaceutical companies identify new drug development opportunities.

In return, these relationships could help us establish clinical utility for our tests and

create new testing opportunities related to emerging therapies.

In return, these relationships could help us establish clinical utility for our tests and create new testing opportunities related to emerging therapies.

Results are typically delivered within seven days following receipt of sample and delivered by a clinical report.

In addition, we expect to expand our MRD portfolio to include a tissue-informed test.

According to American Cancer Society:

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These products could enable clinicians to precisely detect, and intervene in the disease evolution when the disease is more likely to be curable, key to significantly improving patient clinical outcomes.

In order to systematically address this need, in May 2022, we launched the Shield LDT test to address the needs of individuals eligible for colorectal cancer screening.

In order to systematically address this need, we offer the Shield blood test to address the needs of individuals eligible for colorectal cancer screening.

From a simple blood draw, Shield uses a novel multimodal approach to detect colorectal cancer signals in the bloodstream, including DNA that is shed by tumors.

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For this reason, we have incorporated epigenomic signatures to enhance the performance of our Shield assay in these settings.

The test demonstrated 83% sensitivity in detecting individuals with colorectal cancer.

Specificity was 90% in both individuals without advanced neoplasia and in those who had a negative colonoscopy result.

These results exceed the performance criteria set forth by the Centers for Medicare and Medicaid Services, or CMS, for reimbursement.

This test also demonstrated 13% sensitivity in detecting advanced adenomas.

Based on these study results, in March 2023, we submitted a PMA for our Shield blood test to the FDA.

Shield is also the first blood test for colorectal cancer screening that meets coverage requirements by Medicare.

Shield is the first blood test approved by the FDA for primary colorectal cancer screening and also the first blood test for colorectal cancer screening that meets coverage requirements by Medicare.

In addition, our Shield blood test is included in the National Comprehensive Cancer Network colorectal cancer screening guidelines.

We also expect to expand into lung cancer screening and multi-cancer detection, or MCD, with our Shield platform.

To clinically validate the performance of our next-generation Shield blood test in lung cancer screening in high-risk individuals ages 50-80, in January 2022, we initiated a nearly 10,000-patient prospective, registrational study, which we refer to as the SHIELD LUNG study.

In addition, in January 2025, our Shield MCD test was selected for the Vanguard study funded by the National Cancer Institute, part of the National Institutes of Health.

The Vanguard study is a four-year pilot study which will enroll up to 24,000 people to inform the design of a randomized controlled trial evaluating the use of MCD tests for cancer screening.

In addition, we have expanded our Shield blood test to include an MCD results report with a data collection effort to better understand the clinical impact of MCD results.

Patients are now able to receive an MCD results report when they take a Shield colorectal cancer test by agreeing to participate in a clinical data collection initiative.

We believe that developing a blood test for early detection of cancer requires a vast amount of molecular and clinical data across all stages of the disease in order to better understand the biology and clinical relevance of tumor-specific biomarkers in blood.

While we believe the benefits of early detection on clinical outcomes are widely known, early detection may also benefit biopharmaceutical companies by identifying a much larger at-risk population who may benefit from early therapeutic intervention or from preventative medicines.

We also believe Shield is a platform that can expand well beyond cancer into many other diseases.

Biopharmaceutical Offerings

GuardantINFINITY Test

Our GuardantINFINITY test is a next-generation Smart Liquid Biopsy test that provides new, multi-dimensional insights into the complexities of tumor molecular profiles and immune response to advance cancer research and therapy development.

Our GuardantINFINITY test, powered by the Smart Platform, provides new, multi-dimensional insights into the complexities of tumor molecular profiles and immune response to advance cancer research and therapy development.

Our GuardantINFINITY assay provides a more comprehensive molecular profile of tumors than earlier assays, giving researchers access to novel genomic and epigenomic insights to provide a simultaneously deeper and more complete understanding of a tumor’s biology, its system-wide interactions and the associated immune response in a range of applications, from therapy selection to molecular response and longitudinal monitoring.

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Our GuardantOMNI test covers 500 genes, including genes associated with homologous recombination repair deficiency and biomarkers for immuno-oncology applications, such as tumor mutational burden and microsatellite instability.

The test has a significantly larger genomic panel footprint than the Guardant360 LDT test and has achieved comparable analytical performance in clinical studies, with the implemented additional enhancements to the assay efficiency and bioinformatics analysis to improve the sensitivity of our GuardantOMNI test.

The test has a significantly larger genomic panel footprint than the Guardant360 Liquid test and has achieved comparable analytical performance in clinical studies, with the implemented additional enhancements to the assay efficiency and bioinformatics analysis to improve the sensitivity of our GuardantOMNI test.

These enhancements are critical in the context of using the GuardantOMNI test in the retrospective testing of clinical study samples for translational science applications in collaboration with biopharmaceutical customers, as those samples are often available with only a limited volume of plasma.

Validation data indicates that the GuardantOMNI test exceeds the Guardant360 LDT test’s sensitivity for detecting clinically actionable biomarkers.

At the same time, broader panel-wide performance of small variants is roughly similar to that of Guardant360 LDT test.

Validation data indicates that the GuardantOMNI test exceeds the Guardant360 Liquid test’s sensitivity for detecting clinically actionable biomarkers.

At the same time, broader panel-wide performance of small variants is roughly similar to that of Guardant360 Liquid test.

In addition, the broad genomic footprint of our GuardantOMNI test enables accurate measurement of tumor mutational burden.

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GuardantConnect is our integrated software-based solution designed for our clinical and biopharmaceutical customers, seeking to connect patients tested with our assays with actionable alterations with potentially relevant clinical studies.

Smart Liquid Biopsy Platform

Our Smart Liquid Biopsy platform drives significant research and development efficiencies and operating leverage, which supports performance improvements, cross-development of new applications, cost savings and improved turnaround time.

While products continue to evolve by leveraging commonality in equipment, reagents, and staffing, this platform also provides a foundation for future product evolutions and data integration.

We believe our Smart Liquid Biopsy platform has the potential to unlock the power of the epigenome, broaden the view of what drives cancer biology, and provide industry leading high-sensitivity genomic and epigenomic detection at ultra-high specificity and low cost.

Smart Platform

Our proprietary Smart Platform delivers multiomic insights leveraging genomic, epigenomic, and RNA-based data that are scalable from research to the clinic.

Our Smart Platform drives significant research and development efficiencies and operating leverage, which supports performance improvements, faster turnaround time, cross-development of new applications and cost savings.

Our Smart Platform provides a foundation for potentially faster and more powerful product evolution and valuable data generation by leveraging commonality in equipment, reagents, bioinformatics and staffing.

We believe our Smart Platform is unlocking the power of the epigenome, broadening the understanding of what drives cancer biology while providing industry leading sensitivity at high specificity and low cost.

Clinical Studies and Publications

We are proactively pursuing studies to support the use of our tests as a preferred alternative or complementary to tissue testing to inform first line treatment right after diagnosis and at time of disease progression, with the goal to provide evidence that our tests detect genomic alterations at a similar rate compared to standard of care tissue testing and detects mutations that may not be detected by tissue based testing in the United States, Europe and Asia.

Such a strategy is predicated on the tests’ abilities to offer accurate, reliable and fast guideline-directed comprehensive genotyping for all adult solid tumors without exposing patients to invasive biopsy procedures’ risks, delays or chance of failure.

We publish peer-reviewed studies in order to influence treatment guidelines, to educate clinicians and other oncology stakeholders about the value proposition of our test and to set the stage for reimbursement with private and public payers.

We are proactively pursuing studies to support the use of our genotyping tests as a preferred alternative or complementary approach to tissue testing to inform treatment selection at diagnosis and at disease progression.

These studies are designed to provide evidence that our genotyping tests detect genomic alterations at rates comparable to standard-of-care tissue testing and may identify genomic alterations not detected by tissue-based testing.

Our Guardant Reveal clinical study program evaluates the use of our blood-based tests for minimal residual disease detection and therapy monitoring across multiple cancer types.

These studies are designed to assess the analytical and clinical performance of Guardant Reveal for detecting circulating tumor DNA following treatment, monitoring molecular changes over time, and supporting post-treatment surveillance and response assessment.

In addition, our Shield clinical study program evaluates the performance of our tests in cancer screening, as well as assessing facilitators and barriers to cancer screening.

The primary focus of these studies is to support the use of our tests for primary colorectal cancer screening, following FDA approval of our Shield blood test.

Additional studies seek to evaluate the performance and use of our tests for lung cancer screening and multi-cancer detection in various clinical and population-based settings.

Results from our clinical study programs are disseminated through peer-reviewed scientific publications and scientific meeting presentations to support evidence generation, inform clinical practice discussions, educate clinicians and other oncology stakeholders, and contribute to discussions with public and private payers regarding coverage and reimbursement.

Commercialization

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For clinicians, endorsement by KOLs, utilization by academic centers and inclusion in national treatment guidelines are important, especially for adoption in the local community setting.

We believe that our relationships

with key stakeholders across the oncology space have helped facilitate the use of our tests by clinicians and biopharmaceutical companies.

clinical commercial efforts

We believe that our relationships with key stakeholders across the oncology and primary care space have helped facilitate the use of our tests by clinicians and biopharmaceutical companies.

commercial efforts

We sell our tests to clinical customers in the United States through our targeted sales organization.

Our clinician-focused sales organization in the United States is engaged in sales efforts and promotional activities primarily targeting oncologists, cancer centers and primary care physicians.

Our sales representatives typically have extensive sales-related backgrounds in laboratory testing, therapeutics and oncology.

We have supplemented the team with clinical oncology specialists with extensive medical affairs experience for molecular information support in the field.

Our clinical commercial efforts are focused on driving adoption with academic research institutions and with community oncology practices, including through leading physician networks.

Our sales representatives typically have extensive sales-related backgrounds, including in primary care, laboratory testing, therapeutics and oncology.

We have supplemented the team with clinical oncology and primary care specialists with extensive medical affairs experience support in the field.

Our clinical commercial efforts are focused on driving adoption with community oncology practices, academic research institutions, primary care providers and health systems, and leading physician networks.

As we continue to grow our sales organization, we are also expanding our reach to include large community practices, community oncology networks, integrated delivery payer-owned systems and government medical facilities that are looking for a reliable partner for comprehensive molecular information testing.

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Specifically, we have demonstrated the ability to deploy our technology to partner laboratories such as cancer centers, research organizations and laboratory companies, for the development of test assays based on our technology platform.

We believe that this capability will be important in accelerating adoption of our platform and the performance of our testing in certain countries.

We believe that this capability will be important in accelerating adoption of our platform and the performance of our testing globally.

We are conducting studies in various jurisdictions, and have secured and will continue our efforts to secure reimbursement in several countries.

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In October 2021, we signed a partnership agreement with The Royal Marsden NHS Foundation Trust, or Royal Marsden, a premier cancer center within the United Kingdom, or the UK, for patient care, research and teaching of all types of cancer, and in April 2023, the blood-based cancer testing services based on our digital sequencing platform became available at Royal Marsden testing facility in the UK.

In September 2024, we signed a partnership agreement with the Agostino Gemelli University Polyclinic Foundation IRCCS, one of Italy’s largest and most renowned hospitals known for its advanced oncology services, including diagnostics, treatment, and research, to establish an in-house liquid biopsy testing service within its hospital system.

In May 2018, we formed and capitalized Guardant Health AMEA, Inc., with SoftBank, which we refer to as Guardant AMEA, relating to the sale, marketing and distribution of our tests generally outside the Americas and Europe and to accelerate commercialization of our products in Asia, the Middle East and Africa.

In June 2022, we

purchased all of the shares held by SoftBank and its affiliates, and upon completion of the transaction, we obtained full control over operations of Guardant AMEA throughout the Asia, Middle East and Africa region.

In Japan, we have received regulatory approval of our Guardant360 CDx test as a companion diagnostic for identifying patients who may benefit from treatment with LUMAKRAS™ (sotorasib), Keytruda® (pembrolizumab), Opdivo® (nivolumab), and ENHERTU® (trastuzumab deruxtecan), from Japan's Ministry of Health, Labour and Welfare, or the MHLW.

In September 2024, we signed a partnership agreement with Fondazione Policlinico Universitario Agostino Gemelli IRCCS, or Policlinico Gemelli, one of Italy’s largest and most renowned hospitals known for its advanced oncology services, including diagnostics, treatment, and research, to establish an in-house liquid biopsy testing service within its hospital system, and in December 2025, the liquid biopsy testing service based on our proprietary Guardant360® CDx technology became available at the Policlinico Gemelli facility in Italy.

We have expanded our operations and commercialization of our oncology and screening tests into Asia, the Middle East and Africa, primarily through distributor relationships, direct contacts with hospitals, and laboratory partnerships.

In Japan, we have received regulatory approval of our Guardant360 CDx test as a companion diagnostic for identifying patients who may benefit from treatment with several therapies, from Japan's Ministry of Health, Labour and Welfare, or the MHLW.

In addition, in July 2023, the MHLW granted national reimbursement approval for our Guardant360 CDx test for patients with advanced or metastatic solid tumor cancers in Japan.

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As a result, the potential for more favorable reimbursement associated with becoming a participating provider may be offset by a potential loss of reimbursement for non-covered uses of our tests.

We have provided testing services to patients covered by commercial payers with many cancer types and indications, some of the time as a non-participating provider through 2023.

We received reimbursement for tests across the spectrum of these patients, though for amounts that on average were significantly lower than for participating providers.

Because we are not contracted with these payers, they determine the amount that they are willing to reimburse us for any of our tests and they can prospectively and retrospectively adjust the amount of reimbursement, subject to statue of limitations.

We have provided testing services to patients covered by commercial payers with many cancer types and indications, some of the time as a non-participating provider.

We have received reimbursement for tests across the spectrum of these patients, though for amounts that on average were significantly lower than for participating providers.

Our tests are currently covered by various commercial payers and our reimbursement is directly impacted by their policies.

We have experienced situations where commercial payers proactively reduced the amounts they were willing to reimburse for our tests, and where commercial payers have determined that the amounts previously paid were too high and sought to recover those perceived excess payments by deducting such amounts from payments owed to us.

In addition to our existing covered and contracted payers, various laboratory benefit managers and evidence review organizations working with commercial payers have endorsed coverage of Guardant360 CDx, Guardant360 LDT, Guardant360 TissueNext and Guardant Reveal.

In addition to our existing covered and contracted payers, various laboratory benefit managers and evidence review organizations working with commercial payers have endorsed coverage of our Guardant360 CDx, Guardant360 Liquid, Guardant360 Tissue and Guardant Reveal tests.

Additionally, our Shield blood test has received coverage for patients receiving community care authorized by the U.S.

Department of Veterans Affairs and for active-duty service members and their families through TRICARE, the U.S.

military’s health insurance coverage, with no copay for average-risk individuals ages 45 and older.

We are actively engaged to expand coverage among existing commercial payers and to achieve coverage with the remaining key commercial payers, laboratory benefit managers and evidence review organizations.

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Effective January 1, 2022, Medicare started to reimburse Guardant360 CDx services at the median rate of claims paid by commercial payers.

In March 2022, Palmetto GBA, the Medicare administrative contractor for MolDX, conveyed coverage for our Guardant360 TissueNext test under the existing local coverage determination.

The policy covers our Guardant360 TissueNext test for Medicare fee-for-service patients with advanced solid tumor cancers.

In March 2022, Palmetto GBA, the Medicare administrative contractor for MolDX, conveyed coverage for our Guardant360 Tissue test under the existing local coverage determination.

The policy covers our Guardant360 Tissue test for

Medicare fee-for-service patients with advanced solid tumor cancers.

In July 2022, Palmetto GBA conveyed coverage for our Guardant Reveal test for fee-for-service Medicare patients in the United States with stage II or III colorectal cancer whose testing is initiated within three months following curative intent therapy, with an effective date of December 2021.

In April 2023, Palmetto GBA conveyed coverage for our Guardant360 Response test for fee-for-service Medicare patients in the U.S.

with metastatic or inoperable solid tumors who are on an immune checkpoint inhibitor therapy, tested four to ten weeks from therapy initiation.

Effective January 1, 2024, Medicare has increased the reimbursement rate for our Guardant360 LDT test to the same rate as our Guardant360 CDx test.

Effective January 1, 2024, Medicare has increased the reimbursement rate for our Guardant360 Liquid test to the same rate as our Guardant360 CDx test.

In January 2025, Palmetto GBA granted coverage for our Guardant Reveal test to monitor disease recurrence in patients with colorectal cancer in the surveillance setting following curative intent therapy.

This represents an expansion from the prior Medicare coverage of our Guardant Reveal test for colorectal cancer in the early post-surgical setting only.

In August 2024, following the FDA approval, our Shield blood test met the coverage requirements by Medicare based on the criteria established in its NCD for blood-based colorectal cancer screening tests.

In May 2025, the coverage for our upgraded Guardant360 Tissue test was expanded by Medicare to include both DNA and RNA testing.

In August 2024, following the FDA approval, our Shield blood test met the coverage requirements by Medicare based on the criteria established in its National Coverage Determination for blood-based colorectal cancer screening tests.

The test is covered once every three years for eligible Medicare beneficiaries.

In March 2025, CMS approved ADLT status for our Shield blood test for colorectal cancer screening, which initiated a specific, market-based approach to pricing the test for Medicare patients.

State Medicaid programs make individual coverage decisions for diagnostic tests and have taken steps to control the cost, utilization and delivery of healthcare services.

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Other Considerations

As of January 2025, 21 states, including California, have enacted laws that require biomarker testing to be covered for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of disease or condition if the test is supported by medical and scientific evidence, and these enacted laws will mandate coverage for Guardant360 CDx, Guardant360 LDT, Guardant360 TissueNext, Guardant Response and Guardant Reveal when certain criteria are met.

As of January 2026, 23 states, including California, have enacted laws that require biomarker testing to be covered for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of disease or condition if the test is supported by medical and scientific evidence, and these enacted laws will mandate coverage for Guardant360 CDx, Guardant360 Liquid, Guardant360 Tissue and Guardant Reveal when certain criteria are met.

In addition, several more states have current legislation in progress.

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We currently perform clinical, research use only, and investigation use only tests in our laboratory located in Redwood City, California.

Our Redwood City laboratory is certified pursuant to the Clinical Laboratory Improvement Amendments of 1988, or CLIA, accredited by the College of American Pathologists, or CAP, permitted by the New York State Department of Health, or NYSDOH, and licensed in California and four other states.

We also perform research use only tests in our laboratory located in San Diego, California.

In addition, our Redwood City, San Diego and Palo Alto, California laboratories are currently operated as centers for our research and technology development.

Our Redwood City laboratory is licensed pursuant to the Clinical Laboratory Improvement Amendments of 1988, or CLIA, accredited by the College of American Pathologists, or CAP, permitted by the New York State Department of Health, or NYSDOH, and licensed in California and four other states.

We also perform clinical tests in our laboratory located in Long Island City, New York, for which we have received a clinical laboratory license from New York State, and research use only tests in our laboratory located in San Diego, California.

In addition, our Redwood City, San Diego and Palo Alto, California laboratories are currently operated as centers for our research and technology development, and our Palo Alto laboratory is also CLIA licensed.

The proprietary validated methods utilize robust semi-automated workflows designed for high throughput sample testing.

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In September 2014, we entered into a supply agreement with Illumina, Inc., or Illumina, for Illumina to provide products and services that can be used for certain research and clinical activities, including certain sequencers, reagents, and other consumables for use with the Illumina sequencers, as well as service contracts for the maintenance and repair of the sequencers.

in the event a regulatory authority notifies such party that continued performance under the supply agreement would violate applicable laws or regulations.

The initial term of the supply agreement, as amended, continues until January 2033, and automatically renews for additional one-year terms thereafter unless either we or Illumina terminate the supply agreement for the other’s uncured material breach, bankruptcy or insolvency-related events, or in the event a regulatory authority notifies such party that continued performance under the supply agreement would violate applicable laws or regulations.

We may also terminate the supply agreement for convenience upon 90 days’ prior written notice.

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Our competitors within the liquid biopsy space for therapy selection include Foundation Medicine, Inc., which was acquired by Roche Holdings, Inc.

Caris Life Science;

Caris Life Sciences, Inc.;

Tempus AI, Inc.;

NeoGenomics Laboratories, Inc.;

Exact Sciences Corp.;

Myriad Genetics, Inc.;

NeoGenomics, Inc.;

Exact Sciences Corporation;

BillionToOne, Inc.;

Quest Diagnostics, Inc.;

and Laboratory Corporation of America.

In addition, Natera, Inc., Tempus AI, Inc., Exact Sciences Corp., Myriad Genetics, Inc., Caris Life Science, Foundation Medicine, Inc.

and Quest Diagnostics, Inc., among others, are our competitors in minimal residual disease detection.

Additionally, our competitors in the early screening testing space include GRAIL, Inc., Exact Sciences Corp., Freenome Holdings, Inc., and Delfi Diagnostics.

Competitors within the broader genomics profiling space based on tissue include laboratory companies such as Bio-Reference Laboratories, Inc., Laboratory Corporation of America and Quest Diagnostics, Inc., and most if not all of the competitors within the liquid biopsy space for therapy selection, that sell molecular diagnostic tests for cancer to physicians and have or may develop tests that compete with our tests.

In addition, Natera, Inc., Tempus AI, Inc., Exact Sciences Corporation, Myriad Genetics, Inc., Caris Life Sciences, Inc.

Foundation Medicine, Inc., BillionToOne, Inc., Personalis, Inc., and Quest Diagnostics, Inc., among others, are our competitors in minimal residual disease detection.

Additionally, our competitors in the early screening testing space include GRAIL, Inc., Exact Sciences Corporation, Freenome Holdings, Inc., Natera, Inc., and Delfi Diagnostics.

Competitors within the broader genomics profiling space based on tissue include most if not all of the competitors within the liquid biopsy space for therapy selection, that sell molecular diagnostic tests for cancer to physicians and have or may develop tests that compete with our tests.

In addition, we are aware that certain of our customers are also developing their own tests and may decide to enter our market or otherwise stop using our tests.

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The FDA regulates, among other things, the research, design, development, pre-clinical and clinical testing, manufacturing, safety, effectiveness, packaging, labeling, storage, recordkeeping, pre-market clearance or approval, adverse event reporting, marketing, advertising and promotion activities, sales, distribution and import and export of medical devices to ensure that medical devices distributed domestically are safe and effective for their intended uses and otherwise meet the requirements of the FDCA.

Unless an exemption applies, each new or significantly modified medical device we seek to commercially distribute in the United States will require either a premarket notification to the FDA requesting permission for commercial distribution under Section 510(k) of the FDCA, also referred to as a 510(k) clearance, or approval from the FDA of a PMA application.

Both the 510(k) clearance and PMA processes can be resource intensive, expensive, and lengthy, and require payment of significant user fees.

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The de novo classification process is an alternate pathway to classify medical devices that are automatically classified into Class III but which are low to moderate risk.

A manufacturer can submit a petition for direct de novo review if the manufacturer is unable to identify an appropriate predicate device and the new device or new use of the device presents a moderate or low risk.

A manufacturer can submit a petition for direct de novo review if the manufacturer is unable to identify an appropriate predicate device and the new device or new use of the device

presents a moderate or low risk.

De novo classification may also be available after receipt of a “not substantially equivalent” letter following submission of a 510(k) to FDA.

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Certain changes to an approved device, such as changes in manufacturing facilities, methods, or quality control procedures, or changes in the design performance specifications, which could affect the safety or effectiveness of the device, require submission of a PMA supplement.

PMA supplements often require submission of the same type of

information as a PMA, except that the supplement is limited to information needed to support any changes from the device covered by the original PMA and may not require as extensive clinical data or the convening of an advisory panel.

PMA supplements often require submission of the same type of information as a PMA, except that the supplement is limited to information needed to support any changes from the device covered by the original PMA and may not require as extensive clinical data or the convening of an advisory panel.

Certain other changes to an approved device require the submission of a new PMA, such as when the design change causes a different intended use, mode of operation, and technical basis of operation, or when the design change is so significant that a new generation of the device will be developed, and the data that were submitted with the original PMA are not applicable for the change in demonstrating a reasonable assurance of safety and effectiveness.

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An IDE supplement must be submitted to, and approved by, the FDA before a sponsor or investigator may make a change to the investigational plan that may affect its scientific soundness, study plan or the rights, safety or welfare of human subjects.

During a study, the sponsor is required to comply with the applicable FDA requirements, including, for example, study monitoring, selecting clinical investigators and providing them with the investigational plan, ensuring IRB review, adverse event reporting, record keeping and prohibitions on the promotion of investigational devices or on making safety or effectiveness claims for them.

making safety or effectiveness claims for them.

The clinical investigators in the clinical study are also subject to FDA’s regulations and must obtain patient informed consent, rigorously follow the investigational plan and study protocol, control the disposition of the investigational device, and comply with all reporting and recordkeeping requirements.

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The goal of the program is to provide patients and healthcare providers with more timely access to qualifying devices by expediting their development, assessment and review, while preserving the statutory standards for PMA approval, 510(k) clearance and de novo classification.

The program is available to medical devices that

meet certain eligibility criteria, including that the device provides more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions, and that the device meets one of the following criteria:

The program is available to medical devices that meet certain eligibility criteria, including that the device provides more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions, and that the device meets one of the following criteria:

(i) the device represents a breakthrough technology, (ii) no approved or cleared alternatives exist, (iii) the device offers significant advantages over existing approved or cleared alternatives, or (iv) the availability of the device is in the best interest of patients.

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It is possible that legislation could be enacted into law or regulations or guidance could be issued by the FDA which may result in new or increased regulatory requirements for us to continue to offer our LDTs or to develop and introduce new tests as LDTs.

For example, in recent years, FDA has stated its intention to modify its enforcement discretion policy with respect to LDTs.

Specifically, on July 31, 2014, the FDA notified Congress of its intent to modify, in a risk-based manner, its policy of enforcement discretion with respect to LDTs.

On October 3, 2014, the FDA issued two draft guidance documents titled “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs),” or the Framework Guidance, and “FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs),” or the Reporting Guidance.

The Framework Guidance stated that FDA intends to modify its policy of enforcement discretion with respect to LDTs in a risk-based manner consistent with the classification of medical devices generally in Classes I through III.

The Reporting Guidance would have further enabled FDA to collect information regarding the LDTs currently being offered for clinical use through a notification process, as well as to enforce its regulations for reporting safety issues and collecting information on any known or suspected adverse events related to the use of an LDT.

On November 18, 2016, the FDA announced that it would not finalize either guidance document to allow for further public discussion on an appropriate oversight approach to LDTs and to give Congressional authorizing committees the opportunity to develop a legislative solution, and the FDA issued a discussion paper on possible approaches to LDT regulation in January 2017.

In May 2024, the FDA finalized a rule requiring LDTs to undergo premarket review as medical devices.

While the rule is set to be implemented in the spring of 2025, it has been challenged in two separate lawsuits in federal court.

The FDA could ultimately subject LDTs to additional regulatory requirements.

Moreover, legislative measures could result in a change to the approach to FDA’s regulation over LDTs, including a requirement for premarket review of LDTs, among other things.

For example, in 2024 the agency issued a final rule that would have subjected many LDTs to medical device requirements, including premarket review and quality system regulations.

That rule was subsequently vacated by a federal court and rescinded, restoring the prior status quo under which LDTs are primarily regulated under CLIA and the FDA generally does not enforce device requirements.

However, the FDA has not disclaimed its view that it has statutory authority to regulate LDTs, and future rulemaking, legislation, or other regulatory action could impose additional requirements on some or all LDTs.

Any such changes could increase our compliance costs, delay test development or commercialization, limit our ability to offer certain assays, or otherwise adversely affect our business, financial condition, and results of operations.

Research use only or investigational use only devices

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In August 2014, the FDA issued final guidance clarifying the requirements that will apply to approval of therapeutic products and in vitro companion diagnostics.

According to the guidance, if the FDA determines that a companion diagnostic device is essential to the safe and effective use of a novel therapeutic product for that indication, the FDA may will not approve the drug or new indication if the companion diagnostic device is not also approved or cleared for that indication.

According to the guidance, if the FDA determines that a companion diagnostic device is essential to the safe and effective use of a novel therapeutic product for that indication, the FDA may not approve the drug or new indication if the companion diagnostic device is not also approved or cleared for that indication.

Approval or clearance of the companion diagnostic device will ensure that the device has been adequately evaluated and has adequate performance characteristics in the intended population.

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Employees and Human Capital

Our Employees and Commitment to Diversity, Equity and Inclusion

Our Employees

As of December 31, 2025, we had 2,506 employees, 2,490 of which are full-time employees and approximately 2,278 of which are in the U.S., with the remainder in Asia, Europe and Canada.

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None of our employees are represented by a labor union or covered by a collective bargaining agreement, except as required by local laws such as in some European countries, and we have never experienced any employment-related work stoppages.

We also track voluntary and involuntary turnover rates, conduct frequent employee engagement surveys, and consider relations with our employees to be good.

As part of our mission to conquer cancer, we continue to advance our environmental, social and governance efforts, including enhancing the diversity and inclusiveness of our workplace.

We believe that diversity of backgrounds and ideas inspires creativity and helps us create the innovative technologies that patients need.

We appreciate one another’s differences and strengths and we are proud to be an equal opportunity employer.

We also track voluntary and involuntary turnover rates and conduct periodic employee engagement surveys.

As part of our mission to conquer cancer, we continue to advance our human capital management practices, including efforts to maintain a workforce with diverse backgrounds and perspectives.

We believe that a workforce with diverse backgrounds and perspectives supports innovation and the development of technologies for patients.

We do not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by applicable law.

All employment is decided on the basis of qualifications, merit, and business need.

Further, we have policies in place that prohibit harassment of all kinds.

We maintain an inclusive culture where all employees feel empowered to be their authentic selves.

We respect and appreciate each employee’s unique perspective and experiences, and value their contribution to our mission.

It is important that we celebrate, encourage and support similarities and differences to drive innovation for the benefit of our employees, patients and community.

We are proud to employ a diverse workforce that, as of December 31, 2024, was 55% racially/ethnically diverse and 54% female.

For leadership positions across the company, which is defined as director level and above, 32% self-identified as racially/ethnically diverse and 40% self-identified as women.

All employment decisions are based on qualifications, merit, and business need, consistent with applicable law.

Further, we have policies in place that prohibit all forms of harassment.

We maintain policies and practices intended to promote a respectful and professional workplace and to prohibit harassment and discrimination of any kind.

As of December 31, 2025, based on self-identified data, our workforce was approximately 51% racially/ethnically diverse and 53% female.

For leadership positions across the company, which are defined as director level and above, 32% self-identified as racially/ethnically diverse and 40% self-identified as women.

As of December 31, 2025, women held 33% of the independent director seats on our Board.

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What changed 10-K

Item 1. Business