−Removed: We are a leading precision oncology company focused on helping conquer cancer globally through use of our proprietary tests, vast data sets and advanced analytics.
−Removed: Today our proprietary tests are helping to realize the full potential of precision oncology by providing patients and their doctors critical insights that can inform decisions at all stages of the disease, from screening, to monitoring cancer recurrence, to treatment decisions.
−Removed: We believe that the key to conquering cancer is unprecedented access to its molecular information throughout all stages of the disease, which we intend to enable by our tests.
−Removed: By looking at the unique dimensions of cancer found in blood, including genomic alterations, methylation, and fragmentomics, we are unlocking insights that can increasingly help patients across all stages of cancer, including at its earliest, when it’s most treatable.
−Removed: To help identify cancer at the earliest stages, we are developing Guardant SHIELD, a blood test for cancer screening in average-risk adults without symptoms, that detects very early signs of cancer by interrogating genomic alterations, methylation, and fragmentomic signals from a simple blood draw.
−Removed: In pursuit of our goal to manage cancer across all stages of the disease, we provide our Guardant360, Guardant360 LDT, Guardant360 CDx and GuardantOMNI liquid biopsy-based tests for advanced stage cancer.
−Removed: Our Guardant360 CDx test was the first comprehensive liquid biopsy test approved by the U.S.
−Removed: 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.
−Removed: In February 2021, we launched our Guardant Reveal liquid biopsy-based tests for residual and recurring cancer to first address the need in Stage II-III colorectal cancer.
−Removed: In June 2021, we launched Guardant360 TissueNext, our first tissue-based test which will be used to identify patients with advanced cancer who may benefit from biomarker-informed treatment, and Guardant360 Response which will be used to measure early indications to patients' response to treatment up to eight weeks earlier than response evaluation criteria in solid tumors.
−Removed: We have also developed our GuardantINFORM platform to further accelerate precision oncology drug development by biopharmaceutical companies by offering them an in-silico research platform to unlock further insights into tumor evolution and treatment resistance across various biomarker-driven cancers.
−Removed: Therapy selection in advanced stage cancer patients - We are pioneering the clinical comprehensive biopsy market with our tests.
−Removed: Our Guardant360 test is a molecular diagnostic test measuring 74 cancer-related genes, our Guardant360 CDx was the first comprehensive liquid biopsy test approved by the FDA, measuring 55 cancer-related genes, and our GuardantOMNI test has a broader 500-gene panel, all of which analyze circulating tumor DNA in blood.
−Removed: Per American Cancer Society:
−Removed: 2021 Cancer Facts & Figures, there is an estimated 1.9 million new cancer cases diagnosed and 600,000 cancer deaths in the United States.
−Removed: Our Guardant360 test has been used over 250,000 times by clinicians to help inform which therapy may be effective for advanced stage cancer patients with solid tumors.
−Removed: Our tests are used by biopharmaceutical companies for a range of applications, including identifying target patient populations to accelerate translational science research and clinical study enrollment, companion diagnostic development, and post-approval commercialization.
−Removed: The increasing diversity of targeted therapies and associated molecular biomarkers has given rise to comprehensive genomic profiling, particularly in tumor types where multiple genomic targets can be found and treated effectively.
−Removed: For example, NSCLC, like other tumors, has multiple effective treatment options targeting different genomic mutations.
−Removed: There are nine targetable genes in NSCLC, which are comprised of alterations across all four genomic variant classes (SNVs, indels, CNVs, and fusions), as well as TMB.
−Removed: Five of these targets are on-label approved biomarkers for FDA-approved therapies.
−Removed: The NCCN treatment guidelines recommended testing for all of the genomic mutations or alterations across different cancer types, which demonstrates the requirement for broader genomic profiling.
−Removed: Neoadjuvant and adjuvant treatment selection in early-stage cancer patients and surveillance in cancer survivors - We have launched the Guardant Reveal test as a laboratory developed test, or LDT, to detect minimal residual disease which we believe can help identify recurrence earlier than traditional modalities in cancer survivors and potentially identify early-stage cancer patients who may benefit from adjuvant treatment.
−Removed: Our Guardant Reveal test leverages data and learnings from our tests and is designed to enable clinicians to detect minimal residual disease and to detect cancer recurrence at a stage when intervention may have a higher chance of success.
−Removed: For early-stage solid tumors, neoadjuvant and adjuvant treatment may be given as a first step in care to shrink the tumor or adjuvantly as a secondary treatment after the primary treatment to reduce the risk of recurrence.
−Removed: However, not all early-stage cancer patients may benefit from neoadjuvant and adjuvant treatment.
−Removed: For instance, based on data published in 2007 from a randomized study of adjuvant chemotherapy versus observation in patients with colorectal cancer, the use of adjuvant treatment showed significant benefit for a subgroup of the patients who meet certain clinical criteria, but only marginal benefit for the patients who do not meet these criteria.
−Removed: We believe our Guardant Reveal test may also help biopharmaceutical companies identify new drug development opportunities.
−Removed: In return, these relationships could help us establish clinical utility for our tests and create new testing opportunities related to emerging therapies.
−Removed: Early detection of cancer in asymptomatic individuals eligible for cancer screening - We are developing the Guardant SHIELD assay to support cancer screening in asymptomatic individuals including who are eligible for colorectal cancer screening based on the 2016 U.S.
−Removed: Preventive Services Task Force, or USPSTF, guidelines for colorectal cancer screening.
−Removed: Per American Cancer Society:
−Removed: Colorectal Cancer Facts & Figures 2020-2022, it is estimated that only 66% of adults at 50 years and older are screened despite compelling evidence that routine cancer screening can reduce colorectal cancer mortality, the second leading cause of cancer death.
−Removed: Therefore, we believe there is a significant unmet need for non-invasive modalities such as our Guardant SHIELD assay that, if successfully developed, we believe could increase compliance with the USPSTF guidelines.
−Removed: We are also pursuing further development of our Guardant SHIELD assay to support screening for additional cancer types in asymptomatic individuals recommended by the USPSTF and cancer types without a reference standard for screening.
−Removed: To clinically validate the performance of our multi-cancer screening device in detecting lung cancer, we enrolled the first patient in a nearly 10,000-patient prospective, registrational study, which we refer to as the SHIELD study, to detect lung cancer in high-risk individuals ages 50-80 and the study is anticipated to run in approximately 100 centers in the United States and Europe.
−Removed: 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.
−Removed: 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.
−Removed: Guardant Health Oncology Platform - Our Guardant Health Oncology Platform is designed to leverage our capabilities in technology, clinical development, regulatory and reimbursement to drive commercial adoption, accelerate drug development, improve patient clinical outcomes and lower healthcare costs.
−Removed: We believe our Guardant Health Oncology Platform has developed strengths across five critical layers, each of which facilitates success in the adjacent layers, and together the five layers form a barrier to entry and provide us a competitive advantage and a platform we can efficiently leverage across multiple products.
−Removed: The five layers of our Guardant Health Oncology Platform are as follows:
−Removed: Technology - Our proprietary Guardant Health digital sequencing technology combines cutting edge capabilities from multiple disciplines including biochemistry, next-generation sequencing, signal processing, bioinformatics, machine learning and process engineering to enable what we believe to be the world’s market leading comprehensive test with a typical turnaround time of less than seven days after we receive the sample and enable our high performing tests intended for different market segments.
−Removed: Furthermore, our machine learning capability enables performance improvement as we incorporate additional data.
−Removed: Clinical utility - We believe that success in the clinical utility layer requires both independent investments in clinical research and strategic relationships with market-leading biopharmaceutical companies.
−Removed: We have invested heavily in clinical studies, including more than 60 clinical outcomes studies demonstrating that overall biomarker detection rates of our non-invasive blood testing were in line with standard of care tissue testing.
−Removed: Our clinical research collaborations have resulted in more than 200 peer-reviewed publications.
−Removed: We also have relationships with over 60 biopharmaceutical customers that have provided rigorous clinical validation of our technology and early insights into test opportunities for emerging therapeutics.
−Removed: Regulatory approval - We believe our Guardant360 test was the first comprehensive liquid biopsy approved by the New York State Department of Health, or NYSDOH.
−Removed: In addition, based on our review of publicly available records, we believe our facility was the first comprehensive liquid biopsy laboratory to be certified pursuant to the Clinical Laboratory Improvement Amendments of 1988, or CLIA, accredited by the College of American Pathologists, or CAP, and NYSDOH-permitted.
−Removed: Our Guardant360 CDx test was the first comprehensive liquid biopsy test approved by the FDA, to provide tumor mutation profiling with solid tumors and to be used as a companion diagnostic in connection with NSCLC, patients who may benefit from treatment with osimertinib (EGFR exon 19 deletions, exon 20 T790M or exon 21 L858R mutations), amivantamab-vmjw (EGFR exon 20 insertion mutations), and sotorasib (KRAS G12C mutations), which have been developed by our biopharmaceutical customers AstraZeneca, Janssen Biotech and Amgen, respectively.
−Removed: Payer coverage and reimbursement - We believe that the analytical and clinical data that we have generated in our efforts to establish clinical utility, combined with the support we have developed with key opinion leaders, or KOLs, in the oncology space have led to positive coverage decisions by a number of commercial payers.
−Removed: Our guardant360 test is currently covered by various commercial and governmental payers, including Medicare.
−Removed: With respect to Medicare, in July 2018, Palmetto GBA, or Palmetto, the Medicare Administrative Contractor, or MAC, responsible for administering Medicare’s Molecular Diagnostic Services Program, or MolDx, issued a local coverage determination, or LCD, for our Guardant360 test with respect to NSCLC patients who meet certain clinical criteria, and in May 2020, Noridian Healthcare Solutions, or Noridian, the MAC responsible for adjudicating claims in California, where our laboratory is located, and a participant in MolDx, issued a coverage article and confirmed limited Medicare coverage for our Guardant360 test for qualifying patients diagnosed with solid tumor cancers of non-central nervous system origin who meet the criteria of Medicare’s National Coverage Determination for Next Generation Sequencing (90.2) first established in March 2018, or the NGS NCD.
−Removed: Following FDA approval of our Guardant360 CDx test, a new Z-Code Identifier was issued in August 2020.
−Removed: In January 2021, a proprietary laboratory analyses, or PLA code was issued for our Guardant360 CDx with an effective date in April 2021.
−Removed: Additionally, based on this new PLA code, we applied to the Centers for Medicare and Medicaid Services or CMS for our Guardant360 CDx test to become an advanced diagnostic laboratory test, or ADLT.
−Removed: In March 2021, CMS approved ADLT status to the Guardant360 CDx test, based on which Medicare paid us at the lowest available commercial rate per test, from April 1, 2021, to December 31, 2021.
−Removed: After this period, Medicare would reimburse Guardant360 CDx services at the median rate of claims paid by commercial payers.
−Removed: We are in the process of negotiating reimbursement for our Guardant Reveal, Guardant Response and Guardant360 TissueNext tests from commercial and governmental payers.
−Removed: Commercial adoption - Success in each of the layers above is important for commercial adoption of our tests by clinicians and biopharmaceutical companies.
−Removed: Additionally, 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 where 80% of cancer treatment occurs.
−Removed: We believe that our relationships with key stakeholders across the oncology space, clinical data we believe to support use of Guardant360 test ahead of tissue-based testing, as well as the inclusion of liquid biopsy as a potential alternative under certain circumstances to tissue biopsy in NCCN guidelines, have helped facilitate the use of our tests by 11,000 oncologists, who have collectively ordered our Guardant360 test over 250,000 times, and over 100 biopharmaceutical companies.
−Removed: We sold 87,600 tests to clinical customers in the year ended December 31, 2021, an increase from 63,254 and 49,926 in the years ended December 31, 2020 and 2019, respectively.
−Removed: We sold 18,600 tests to biopharmaceutical customers in the year ended December 31, 2021, compared to 15,983 and 20,643 in the years ended December 31, 2020 and 2019, respectively.
+Added: We are a leading precision oncology company focused on helping conquer cancer globally through the use of our proprietary tests, vast data sets and advanced analytics.
+Added: We believe our tests can transform cancer care by unlocking insights that will help patients at all stages of the disease, including at its earliest stages, when it’s most treatable.
+Added: 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.
+Added: 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.
+Added: 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 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.
+Added: 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, launched in September 2022, which is 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.
+Added: 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.
+Added: In May 2022, we launched the Shield LDT test to address the needs of individuals eligible for colorectal cancer screening.
+Added: 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.
+Added: In addition, in December 2022, we announced positive results from ECLIPSE, an over 20,000 patient registrational study evaluating the performance of our Shield blood test for detecting colorectal cancer in average-risk adults.
+Added: We also expect to expand into lung and multi-cancer screening with our investigational, next-generation Shield assay.
Our objective is to be the leading provider of precision oncology and screening products for cancer management across all stages of the disease and drive commercial adoption of our products.
2 unchanged sentences
▪ building awareness of liquid biopsy and pioneering a blood-first paradigm for genotyping cancer patients;
−Removed: ▪ educating biopharmaceutical companies, KOLs and advocacy groups;
+Added: ▪ educating biopharmaceutical companies, key opinion leaders, or KOLs, and advocacy groups;
▪ advocating for inclusion of our tests in treatment guidelines;
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▪ providing earlier insights into emerging clinically relevant biomarkers.
−Removed: • Leverage our Guardant Health Oncology Platform to expand our product portfolio by:
+Added: • 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;
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Our products and development program
−Removed: We have launched various products and programs, and we believe our product portfolio, once completed, will address the full continuum of cancer care and has utility in both the clinical and biopharmaceutical markets.
+Added: 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.
+Added: 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.
Therapy Selection
Guardant360 CDx Test
−Removed: We believe our Guardant360 CDx test is the market leading comprehensive liquid biopsy test, based on the number of tests ordered.
−Removed: Guardant360 CDx test is a 55 gene test, approved by the FDA 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, and as a companion diagnostic to identify NSCLC patients who may benefit from certain targeted therapies, currently including TAGRISSO ® (osimertinib), RYBREVANT TM (amivantamab-vjmw) and LUMAKRAS TM (sotorasib), which supports treatment selection for advanced stage cancer patients with solid tumors.
+Added: We believe our Guardant360 CDx test was the first comprehensive liquid biopsy test approved by the FDA, and is the market leading comprehensive liquid biopsy test, based on the number of tests ordered.
+Added: Our Guardant360 CDx test is a 55-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.
+Added: 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 TM (amivantamab-vjmw), LUMAKRAS TM (sotorasib) and ENHERTU ® (fam-trastuzumab deruxtecan-nxki), and breast cancer patients who may benefit from treatment with ORSERDU TM (elacestrant), marketed by biopharmaceutical companies.
Additional gene content and immune-oncology biomarkers (e.g.
−Removed: MSI) are reported in a professional services compendium to the FDA approved CDx report.
+Added: 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.
−Removed: Guardant360 LDT Test
+Added: Guardant360 LDT
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.
−Removed: Focused on addressing patient care throughout the diagnostic journey, we launched an updated and expanded version of our LDT in 2020 to support new guideline-recommended biomarkers, including our industry leading plasma-based tumor mutational burden or TMB, MSI-High, expanded homologous recombination repair or HRR gene set, and full coverage of neurotrophic receptor tyrosine kinase or NTRK fusions.
−Removed: The Guardant360 LDT ensures progressing patients are given the opportunity to be eligible for these new treatment options, without the need to obtain archival tissue or subject the patient to another invasive biopsy.
+Added: Focused on addressing patient care throughout the diagnostic journey, we launched an updated and expanded version of our LDT to support new guideline-recommended biomarkers.
+Added: Our Guardant360 LDT test measures 80+ cancer-related genes, and has been used over 300,000 times by clinicians 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.
Results are typically delivered, ten days following receipt of sample and delivered by a clinical report.
Guardant360 Response Test
−Removed: In June 2021, we launched Guardant360 Response test as an LDT, which is the first blood-only liquid biopsy that enables doctors to view molecular response, or changes in circulating tumor DNA (ctDNA) levels, from a simple blood draw to potentially gain early insight regarding patient response to treatment.
+Added: Our Guardant360 Response test, launched as an LDT, is the first blood-only liquid biopsy that enables doctors to view molecular response, or changes in circulating tumor DNA (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.
−Removed: Studies across cancers and therapies show the Guardant360 Response test predicted treatment response 8 weeks earlier than current standard-of-care radiological and imaging scans.
+Added: 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
−Removed: To complement our liquid biopsy-based products, we launched Guardant360 TissueNext as an LDT in June 2021, our first tissue-based test which is designed to identify patients with advanced cancer who may benefit from biomarker-informed treatment.
+Added: To complement our liquid biopsy-based products, we launched Guardant360 TissueNext as an LDT, our first tissue-based test which 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.
2 unchanged sentences
We therefore believe our Guardant360 TissueNext, together with our liquid biopsy-based products, have the potential to help address the challenges with tissue genotyping products currently in the market.
−Removed: Guardant360 clinical report
−Removed: A typical Guardant360 CDx and Guardant360 clinical report contains somatic mutations, immuno-oncology markers detected in patient blood samples, associated treatment options and available clinical studies in the vicinity of the patient’s location.
−Removed: Additionally, the report depicts a proprietary visual representation that shows the evolution of somatic mutations in longitudinal blood samples.
−Removed: Clinical studies and publications
−Removed: The goal of our clinical development with our tests is to support its use for comprehensive genomic profiling across multiple tumor types, including as a preferred alternative to tissue testing to inform first line treatment right after diagnosis and at time of disease progression.
−Removed: 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.
−Removed: We have over 60 approved, completed or active clinical outcomes studies, more than 200 peer-reviewed publications and more than 400 scientific abstracts.
−Removed: We are proactively pursuing studies to support the use of our tests as a preferred alternative to tissue testing to inform first
−Removed: line treatment right after diagnosis, with the goal to provide evidence that our tests detects genomic alterations at a similar rate compared to standard of care tissue testing in the United States, Europe and Asia.
−Removed: Such a strategy is predicated on the tests’ ability 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.
−Removed: Minimum Residual Disease
+Added: Recurring Monitoring / Minimum Residual Disease
Guardant Reveal Test
In the management of early-stage cancer, current tools do not identify all high-risk patients who will benefit from adjuvant therapy or detect recurrence early enough when it is most curable.
−Removed: We plan to address this need, first in Stage II-III colorectal cancer, with our Guardant Reveal test launched as an LDT in February 2021 for residual disease and recurrence monitoring.
+Added: We plan to address this need, first in early-stage colorectal, breast and lung cancers, with our Guardant Reveal test launched as an LDT 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.
−Removed: Similar to our data development effort for our Guardant360 tests, we are investing very heavily in establishing clinical utility for the use of Guardant Reveal in adjuvant treatment settings.
−Removed: Biopharmaceutical Customers
+Added: Similar to our data development effort for our Guardant360 tests, we are investing heavily in establishing clinical utility for the use of Guardant Reveal in adjuvant treatment settings.
+Added: We also believe our Guardant Reveal test may help biopharmaceutical companies identify new drug development opportunities.
+Added: In return, these relationships could help us establish clinical utility for our tests and create new testing opportunities related to emerging therapies.
+Added: According to American Cancer Society:
+Added: Colorectal Cancer Facts & Figures 2020-2022, it is estimated that only 66% of adults at 50 years and older are screened despite compelling evidence that routine cancer screening can reduce colorectal cancer mortality, the second leading cause of cancer death.
+Added: Therefore, we believe that there is a critical need to develop products to expand precision oncology to earlier stage cancer settings.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: Our research and development results to date indicate that somatic signatures alone may be insufficient for detection of early-stage cancers with high sensitivity.
+Added: For this reason, we have incorporated epigenomic signatures to enhance the performance of our Shield assay in these settings.
+Added: In addition, in December 2022, we announced positive results from ECLIPSE, an over 20,000 patient registrational study evaluating the performance of our Shield blood test for detecting colorectal cancer in average-risk adults.
+Added: The test demonstrated 83% sensitivity in detecting individuals with colorectal cancer.
+Added: Specificity was 90% in both individuals without advanced neoplasia and in those who had a negative colonoscopy result.
+Added: These results exceed the performance criteria set forth by the Centers for Medicare and Medicaid Services, or CMS, for reimbursement.
+Added: This test also demonstrated 13% sensitivity in detecting advanced adenomas.
+Added: Based on these study results, we plan to complete our premarket approval, or PMA, submission to the FDA in the first quarter of 2023.
+Added: We also expect to expand into lung and multi-cancer screening with our investigational, next-generation Shield assay.
+Added: To clinically validate the performance of our next-generation Shield blood test in detecting lung cancer in high-risk individuals ages 50-80, in January 2022, we enrolled the first patient in a nearly 10,000-patient prospective, registrational study, which we refer to as the SHIELD LUNG study.
+Added: The study is anticipated to run in approximately 100 centers in the United States and Europe.
+Added: 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.
+Added: 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.
+Added: Biopharmaceutical Offerings
GuardantOMNI Test
−Removed: Our GuardantOMNI test is built on Guardant Health Digital Sequencing Technology and learnings from our Guardant360 test.
−Removed: The GuardantOMNI test, launched in 2017, has a significantly larger genomic panel footprint than the Guardant360 test and has achieved comparable analytical performance in clinical studies, including for translational science applications in collaboration with several biopharmaceutical companies, including AstraZeneca, Bristol-Myers Squibb, Merck MSD, Merck KGaA of Darmstadt, Germany and Pfizer.
+Added: Our GuardantOMNI test has a significantly larger genomic panel footprint than the Guardant360 LDT test and has achieved comparable analytical performance in clinical studies, including for translational science applications in collaboration with several biopharmaceutical companies.
It 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.
−Removed: In order to preserve performance characteristics of our Guardant360 test across a broader gene panel, we implemented additional enhancements to the assay efficiency and bioinformatics analysis to improve the sensitivity of our GuardantOMNI test.
+Added: In order to preserve performance characteristics of our Guardant360 LDT test across a broader gene panel, we 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.
−Removed: Validation data indicates that the GuardantOMNI test exceeds the Guardant360 test’s sensitivity for detecting clinically actionable biomarkers.
−Removed: At the same time, broader panel-wide performance of small variants is roughly similar to that of Guardant360 test.
+Added: Validation data indicates that the GuardantOMNI test exceeds the Guardant360 LDT test’s sensitivity for detecting clinically actionable biomarkers.
+Added: At the same time, broader panel-wide performance of small variants is roughly similar to that of Guardant360 LDT test.
The broad genomic footprint of our GuardantOMNI test enables accurate measurement of tumor mutational burden.
−Removed: The GuardantOMNI test received breakthrough device designation from the FDA in December 2018.
+Added: GuardantINFINITY Test
+Added: In September 2022, we launched GuardantINFINITY, 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.
+Added: 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.
+Added: The assay’s extensive methylome panel helps identify the unique methylation pattern that each tumor delivers, providing an important new dimension of research insights that has been largely unexplored in clinical development to date.
+Added: GuardantINFINITY is available as a single modular assay with flexible configurations that can be tailored to fit a current application, along with the ability to unlock additional content modules at any time, without incurring the burden or delay of additional sample collection.
+Added: The core module offers genotyping coverage of more than 800 genes with sample-level methylation detection and tumor fraction score for biomarker discovery, clinical research, therapy selection and response monitoring.
GuardantConnect
−Removed: Because metastatic cancer patients often exhaust standard of care treatment options as the disease progresses and guidelines recommend clinical studies for advanced cancer patients, clinical study matching is an acute need in oncology.
+Added: Because cancer patients often exhaust standard of care treatment options as the disease progresses and guidelines recommend clinical studies for cancer patients, clinical study matching is an acute need in oncology.
At the same time, biopharmaceutical companies need to fill clinical studies that require screening hundreds of thousands of patients.
−Removed: Despite these needs, clinical study enrollment in oncology has severely lagged, with only 3-6% of cancer patients enrolling in clinical studies.
−Removed: GuardantConnect is our integrated software-based solution designed for our clinical and biopharmaceutical customers, seeking to connect patients tested with the Guardant360 assay with actionable alterations with potentially relevant clinical studies.
+Added: Despite these needs, clinical study enrollment in oncology has severely lagged, with only approximately 8% of cancer patients enrolling in clinical studies.
+Added: 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.
GuardantINFORM
−Removed: In 2020 we launched GuardantINFORM, our real-world evidence platform featuring an extensive clinical-genomic liquid biopsy dataset of advanced cancer patients.
−Removed: The GuardantINFORM platform is intended to help accelerate research and development of the next generation of cancer therapeutics by offering biopharma partners an in silico
−Removed: resource that combines de-identified longitudinal clinical information and genomic data collected from the Guardant360 liquid biopsy test.
+Added: In June 2020, we launched GuardantINFORM, our real-world evidence platform featuring an extensive clinical-genomic dataset of advanced cancer patients.
+Added: The GuardantINFORM platform is intended to help accelerate research and development of the next generation of cancer therapeutics by offering biopharmaceutical partners an in silico resource that combines de-identified longitudinal clinical information and genomic data collected from our tests.
This robust dataset offers real-world insights into anti-cancer therapy use and associated outcomes, and molecular drivers of treatment response and resistance for over 60 advanced cancers including non-small cell lung, breast, colon, and prostate.
−Removed: Applications for the GuardantINFORM platform include targeted drug development, clinical study optimization and post-marketing studies.
−Removed: Guardant SHIELD
−Removed: We believe that there is a critical need to develop products to expand precision oncology to earlier stage cancer settings.
−Removed: Such products would enable clinicians to precisely detect, monitor and select the appropriate intervention at the right times in the disease’s evolution, key to significantly improving patient clinical outcomes.
−Removed: In order to systematically address this need, we are developing Guardant SHIELD for asymptomatic individuals eligible for cancer screening in line with the USPSTF guidelines and in cancers where screening can reduce mortality.
−Removed: Our research and development results to date indicate that somatic signatures alone may be insufficient for detection of early-stage cancers with high sensitivity.
−Removed: For this reason, we have incorporated epigenomic signatures to enhance the performance of our Guardant SHIELD assay in these settings.
−Removed: Early cancer detection is challenging, especially with respect to clinical sensitivity.
−Removed: There is a minimal amount of ctDNA in patients with low-disease burden.
−Removed: Additionally, naturally occurring genomic aberrations in blood as well as signals from non-cancer related diseases can add biological noise obfuscating detection of circulating tumor-related biomarkers.
−Removed: We believe we have the unique capability to overcome these challenges by leveraging our:
−Removed: • Vast data sets and deep insights:
−Removed: We have targeted deep sequencing data in combination with low coverage sequencing of whole genome from tens of thousands of cancer patients.
−Removed: This data has enabled discovery of novel epigenomic variations across multiple cancer types.
−Removed: We believe augmenting genomic with epigenomic signatures can enhance the clinical sensitivity and specificity of our tests significantly.
−Removed: Moreover, we developed a database of biological noise sources such as clonal hematopoiesis of indeterminate potential, which enables us to further enhance the sensitivity and specificity of our tests.
−Removed: • Extensive blood biobank:
−Removed: We have a biobank of tens of thousands of cancer samples that we use for discovery and, more importantly, biomarker verification and validation.
−Removed: For example, we are analyzing these samples with whole genome sequencing to identify and confirm tumor associated signatures.
−Removed: Also, we have been collecting additional samples through multiple on-going research collaborations.
+Added: Applications for the GuardantINFORM platform cover research and development, clinical study planning and modelling, and commercial applications.
+Added: Smart Liquid Biopsy Platform
+Added: 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.
+Added: 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.
+Added: We expect to migrate our products to the platform and 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.
+Added: Guardant Galaxy
+Added: Our Guardant Galaxy suite of advanced analytical technologies have been developed internally and through outside partnerships to enhance the performance and clinical utility of our portfolio of cancer tests, and to power the next generation of biomarker and drug discovery.
+Added: The first application in the Guardant Galaxy suite is an AI-backed digital pathology platform developed by Lunit®, for the enhanced Guardant360 TissueNext PD-L1 test, which improves detection of the cancer biomarker compared to manual pathologist interpretation in NSCLC cases.
+Added: Future planned applications include deep learning-driven genomic, epigenomic and spatial biomarker discovery via collaboration with biopharmaceutical partners and integration with GuardantINFORM real-world clinical data platform.
+Added: Clinical Studies and Publications
+Added: The goal of our clinical development with our tests is to support its use for comprehensive genomic profiling across multiple tumor types, including as a preferred alternative to tissue testing to inform first line treatment right after diagnosis and at time of disease progression.
+Added: 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.
+Added: We have over 90 targeted therapy outcomes studies, more than 300 peer-reviewed publications and more than 700 scientific abstracts.
+Added: We are proactively pursuing studies to support the use of our tests as a preferred alternative to tissue testing to inform first line treatment right after diagnosis, with the goal to provide evidence that our tests detect genomic alterations at a similar rate compared to standard of care tissue testing in the United States, Europe and Asia.
+Added: Such a strategy is predicated on the tests’ ability 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.
Commercialization
+Added: Successful commercial adoption of our tests by clinicians and biopharmaceutical companies is critical to our business.
+Added: 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 where 80% of cancer treatment occurs.
+Added: We believe that our relationships with key stakeholders across the oncology space have helped facilitate the use of our tests by over 12,000 oncologists, who have collectively ordered our Guardant360 LDT test over 300,000 times, and over 150 biopharmaceutical companies.
clinical commercial efforts
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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.
−Removed: International clinical commercial efforts
−Removed: We currently offer our tests in countries outside the United States primarily through direct contacts with insurers and hospitals and through distributor relationships.
−Removed: Currently, all customer samples are shipped globally to our laboratory in Redwood City, California.
−Removed: We are conducting studies in various jurisdictions and have started efforts to secure reimbursement in several countries.
−Removed: As these studies progress and we near commercial opportunities there, we are seeking to establish in-country laboratories and direct sales organizations.
−Removed: Specifically, we have already demonstrated the ability to deploy our technology to partner laboratories such as cancer centers, for the development of test assays based on our technology platform.
−Removed: We believe that this capability will be important in accelerating adoption of our platform and the performance of our testing in certain countries.
−Removed: Together with SoftBank, we formed a joint venture, Guardant Health AMEA, Inc., which we refer to as the Joint Venture, to accelerate commercialization of our products in Asia, the Middle East, and Africa.
−Removed: There are estimated to be over 400,000 deaths annually in Japan with a significant portion relating to lung and gastric cancers.
−Removed: We are involved in several nationwide clinical programs that help establish clinical utility of our Guardant360 test in the Japanese population with the first patient tested in late 2018.
−Removed: In 2021, an affiliate of the Joint Venture submitted an application to the Ministry of Health, Labour and Welfare, or the MHLW, for regulatory approval of Guardant360 CDx in Japan.
−Removed: In December 2021, the MHLW granted regulatory approval of Guardant360 CDx in patients with advanced solid cancers.
−Removed: In November 2021, we exercised our call right contained in the joint venture agreement with SoftBank to purchase all of the shares held by SoftBank and its affiliates in consideration for the payment of the aggregate purchase price to be determined based on an independent third-party valuation.
−Removed: The aggregate purchase price will be no less than an amount that yields a 20% internal rate of return on the $41.0 million of capital invested by SoftBank in May 2018 as stipulated in the joint venture agreement.
−Removed: SoftBank and us have initiated a process to determine the independent valuation of the Joint Venture, which includes the appointment of independent appraisers by both SoftBank and us.
−Removed: We expect to complete this transaction before the end of the second quarter of 2022.
−Removed: In preparation for wider commercialization in the European Union, or the EU, we obtained a CE mark for our Guardant360 CDx test performed in Redwood City and also achieved ISO15189 accreditation.
−Removed: In 2020, we signed the first public private partnership agreement with Vall D'Hebron Institute of Oncology, one of Europe’s leading cancer research institutions.
−Removed: In 2021, we signed an agreement with The Royal Marsden NHS Foundation Trust, a premier cancer center within the United Kingdom for patient care, research and teaching of all types of cancer.
−Removed: We expect these partnerships will lead to the establishment of our testing services at the partner laboratories, using Guardant Health Digital Sequencing Technology, as well as generation of clinical and economic evidence to support commissioning in other areas of Europe.
Biopharmaceutical commercial efforts
−Removed: Our business development team is focused on enterprise selling to biopharmaceutical companies in the United States and internationally.
−Removed: Our strategy with each biopharmaceutical customer is to demonstrate the value proposition of the Guardant Health Oncology Platform and expand its utilization across the organization from early-stage research through clinical development to commercialization.
−Removed: Given the broad and differentiated utility of our platform, we believe we can support our biopharmaceutical customers across many applications, including:
+Added: Our business development team is focused on enterprise selling to biopharmaceutical companies in the United States and internationally, and we believe we can support our biopharmaceutical customers across many applications, including:
• discovery of new targets and mechanisms of acquired resistance;
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We also expect to be able to capture other commercial opportunities from our genomic data, which can be used in combination with clinical outcomes or claims data for multiple applications, including novel target identification.
+Added: International commercial efforts and expansion
+Added: A component of our long-term growth strategy is to expand our commercial footprint internationally, and we expect to increase our sales and marketing expense to execute on this strategy.
+Added: We currently offer our tests in countries outside the United States primarily through direct contacts with insurers and hospitals, distributor relationships, and laboratory partnerships.
+Added: Specifically, we have already demonstrated the ability to deploy our technology to partner laboratories such as cancer centers, for the development of test assays based on our technology platform.
+Added: We believe that this capability will be important in accelerating adoption of our platform and the performance of our testing in certain countries.
+Added: We are conducting studies in various jurisdictions and have started efforts to secure reimbursement in several countries.
+Added: As these studies progress and we near commercial opportunities there, we are seeking to establish in-country laboratories and direct sales organizations.
+Added: In May 2018, we formed and capitalized a joint venture, Guardant Health AMEA, Inc., with SoftBank, which we refer to as the Joint Venture or 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.
+Added: In February 2021, an affiliate of Guardant AMEA, submitted an application to Japan's Ministry of Health, Labour and Welfare, or the MHLW, for regulatory approval of Guardant360 CDx.
+Added: In December 2021, MHLW granted regulatory approval of Guardant360 CDx as a companion diagnostic for identifying patients with metastatic NSCLC who may benefit from treatment with LUMAKRAS™ (sotorasib).
+Added: In March 2022, MHLW granted regulatory approval of Guardant360® CDx in patients with advanced solid tumors.
+Added: MHLW also approved Guardant360 CDx as a companion diagnostic to identify patients with microsatellite instability-high (MSI-High) solid tumors who may benefit from Keytruda® (pembrolizumab) and patients with MSI-High advanced colorectal cancer who may benefit from Opdivo® (nivolumab).
+Added: In February 2022, we received CAP accreditation for our laboratory in Japan where we expect to commence processing samples following receipt of additional certification for processing In Vitro Diagnostic, or IVD, samples and reimbursement approval.
+Added: As part of our international expansion and to obtain full control over operations throughout the Asia, Middle East and Africa region, in November 2021, we exercised our call right contained in the joint venture agreement with SoftBank to purchase all of the shares held by SoftBank and its affiliates in consideration for the payment of the aggregate purchase price to be determined based on an independent third-party valuation.
+Added: Upon our exercise of the call right in November 2021, SoftBank no longer had the option to exercise its put right.
+Added: In June 2022, we purchased all of the shares held by SoftBank and its affiliates in consideration for a cash payment of the aggregate purchase price of $177.8 million, as determined by an independent valuation firm, which resulted in $99.8 million of fair value adjustments to the noncontrolling interest liability for the year ended December 31, 2022.
+Added: In June 2022, we signed a strategic partnership agreement with Adicon Holdings Limited, a leading independent clinical laboratory company based in China, to offer our industry-leading comprehensive genomic profiling tests to biopharmaceutical companies conducting clinical studies in China.
+Added: We expect the partnership to help biopharmaceutical companies bring the next generation of cancer therapies to patients in the region.
+Added: In preparation for wider commercialization in the European Union, or the EU, we obtained a CE mark for our Guardant360 CDx, Guardant360 LDT, and Guardant Reveal tests.
+Added: In December 2020, we signed our first public private partnership agreement with Vall D'Hebron Institute of Oncology, or VHIO, one of Europe’s leading cancer research institutions, and in May 2022, the first blood-based cancer testing services in Europe based on our industry-leading digital sequencing platform became available at the VHIO testing facility in Spain.
+Added: In October 2021, we signed a partnership agreement with The Royal Marsden NHS Foundation Trust, a premier cancer center within the United Kingdom for patient care, research and teaching of all types of cancer.
+Added: We expect these partnerships will lead to the establishment of our testing services at the partner laboratories, using our digital sequencing technology, as well as generation of clinical and economic evidence to support commissioning in other areas of Europe.
Payer coverage and reimbursement
Commercial payers
−Removed: Payment from commercial payers can vary depending on whether we have entered into a contract with the payers as a “participating provider” or do not have a contract and are considered a “non-participating provider”.
−Removed: Payers often reimburse non-participating providers, if at all, at a lower amount than participating providers.
+Added: Payment from commercial payers can vary depending on whether we have entered into a contract with the payers as a “participating provider” or do not have a contract and are considered a “non-participating provider.” Payers often reimburse non-participating providers, if at all, at a lower amount than participating providers.
When we contract with a payer to serve as a participating provider, reimbursements by the payer are generally made pursuant to a negotiated fee schedule and are limited to only covered indications or where prior approval has been obtained.
Becoming a participating provider can result in higher reimbursement amounts for covered uses of our tests and, potentially, no reimbursement for non-covered uses identified under the payer’s policies or the contract.
−Removed: 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.
−Removed: We have provided testing services to patients covered by commercial payers with many cancer types and indications, most of the time as a non-participating provider through 2021.
+Added: 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.
+Added: 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 2022.
We received reimbursement for tests across the spectrum of these patients, though for amounts that on average were significantly lower than for participating providers.
−Removed: 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.
+Added: 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.
Our tests are currently covered by various commercial payers and our reimbursement is directly impacted by their policies.
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National coverage determinations are made through an evidence-based process by the CMS, with opportunities for public participation.
−Removed: Medicare’s NGS NCD provides coverage for molecular diagnostic tests such as our Guardant360 CDx test, if, among other criteria, such tests are offered within their FDA-approved companion diagnostic labeling.
+Added: Medicare’s National Coverage Determination, or NCD, for Next Generation Sequencing, or NGS, provides coverage for molecular diagnostic tests such as our Guardant360 CDx test, if, among other criteria, such tests are offered within their FDA-approved companion diagnostic labeling.
In March 2020, we began to receive reimbursement from Medicare for claims submitted with respect to Guardant360 clinical tests performed for qualifying patients diagnosed with solid tumor cancers of non-central nervous system origin other than NSCLC.
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On June 23, 2016, CMS published the final rule implementing the reporting and rate-setting requirements under PAMA.
−Removed: Under PAMA, laboratories that receive the majority of their Medicare revenue from payments made under the CLFS were required to report to CMS, beginning in 2017 and every three years thereafter (or annually for “advanced diagnostic laboratory tests”), commercial payer payment rates and volumes for each test they perform.
+Added: Under PAMA, laboratories that receive the majority of their Medicare revenue from payments made under the CLFS were required to report to CMS, beginning in 2017 and every three years thereafter (or annually for “advanced diagnostic laboratory tests” (ADLTs)), commercial payer payment rates and volumes for each test they perform.
CMS uses this data to calculate a weighted median payment rate for each test, which is used to establish revised Medicare CLFS reimbursement rates for the test.
−Removed: As we have begun billing Medicare for our tests, we are subject to reporting requirements under PAMA and the Medicare rate for our tests will be calculated in the future based on our private payer rates.
−Removed: For tests furnished on or after January 1, 2018, Medicare payments for clinical diagnostic laboratory tests are based upon these reported commercial payer rates.
−Removed: On December 10, 2021, Congress passed the Protecting Medicare and American Farmers from Sequester Cuts Act, which delays the next data reporting period by one year and prevents any reduction in payment amounts from commercial payer rate implementation in 2022.
−Removed: Current Procedural Terminology, or CPT, coding plays a significant role in how our Guardant360 test is reimbursed both from commercial and governmental payers.
−Removed: In addition, Z-Code Identifiers are used by certain payers,
−Removed: including under Medicare’s MolDx, to supplement CPT codes for molecular diagnostics tests such as our Guardant360 test.
−Removed: Changes to the codes used to report the Guardant360 test to payers may result in significant changes in its reimbursement.
−Removed: Following the FDA approval of our Guardant360 CDx test, a new Z-Code Identifier was issued in August 2020.
−Removed: In January 2021, a proprietary laboratory analyses, or PLA code was issued for our Guardant360 CDx with an effective date in April 2021.
+Added: We are subject to reporting requirements under PAMA and the Medicare rate for our tests will be calculated based on our private payer rates.
+Added: On December 10, 2021, Congress passed the Protecting Medicare and American Farmers from Sequester Cuts Act, which delayed the next data reporting period by one year and prevented any reduction in payment amounts from commercial payer rate implementation in 2022.
+Added: On November 2, 2022, CMS published its final rule for the Medicare Physician Fee Schedule for calendar year (CY) 2023, including changes for clinical laboratories that take effect on January 1, 2023.
+Added: Changes include updated regulatory definitions to specify the data collection period for the data reporting period of January 1, 2023 through March 31, 2023;
+Added: revisions to indicate that data reporting is required every 3 years beginning January 2023;
+Added: and to confirm that for CY 2022, payment may not be reduced by more than 0% as compared to CY 2021, and for CYs 2023 through 2025, payment may not be reduced by more than 15% as compared to the amount established for the preceding year.
+Added: On December 29, 2022, Congress passed the Consolidated Appropriations Act, 2023, which prevented any reduction in payment amounts from commercial payor rate implementation for 2023;
+Added: delayed by one year data reporting requirements for tests other than ADLTs;
+Added: and extended the three-year period in which payment may not be reduced by more than 15%, to CYs 2024 through 2026.
+Added: Current Procedural Terminology, or CPT, coding plays a significant role in how our tests are reimbursed both from commercial and governmental payers.
+Added: In addition, Z-Code Identifiers are used by certain payers, including under Medicare's MolDx, to supplement CPT codes for our molecular diagnostics tests.
+Added: Changes to the codes used to report to payers may result in significant changes in reimbursement.
+Added: If their policies were to change in the future to cover additional cancer indications, we anticipate that our total reimbursement would increase.
+Added: In January 2021, a PLA code was issued for our Guardant360 CDx test with an effective date in April 2021.
Additionally, based on this new PLA code, we applied to the CMS for our Guardant360 CDx test to become an advanced diagnostic laboratory test, or ADLT.
In March 2021, CMS approved ADLT status to the Guardant360 CDx test, based on which Medicare paid us at the lowest available commercial rate per test, from April 1, 2021 to December 31, 2021.
−Removed: After this period, Medicare would reimburse Guardant360 CDx services at the median rate of claims paid by commercial payers.
−Removed: We are in the process of negotiating reimbursement for our Guardant Reveal, Guardant Response and Guardant360 TissueNext tests from commercial and governmental payers.
−Removed: Additionally, if coding changes were to occur, payments for certain uses of our tests could be reduced, put on hold, or eliminated.
+Added: Effective January 1, 2022, Medicare has started to reimburse Guardant360 CDx services at the median rate of claims paid by commercial payers and this rate will apply until December 2023.
+Added: In March 2022, Palmetto GBA, the Medicare administrative contractor for MolDX, has conveyed coverage for our Guardant360 TissueNext test under the existing local coverage determination.
+Added: The policy covers our Guardant360 TissueNext test for Medicare fee-for-service patients with advanced solid tumor cancers.
+Added: 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.
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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Historic success and payments are not indicative of future success of and payments from such appeals.
−Removed: Due to the inherent variability and unpredictability of the reimbursement landscape, including related to the amount that payers reimburse us for any of our tests, we estimate the amount of revenue to be recognized at the time a test is provided and record revenue adjustments if and when the cash subsequently received for a test differs from the revenue recorded for the test.
+Added: Due to the inherent variability and unpredictability of the reimbursement landscape, including related to the amount that payers reimburse us for any of our tests, we estimate the amount of revenue to be recognized at the time a test is provided and record revenue adjustments if and when the cash subsequently received differs from the revenue recorded.
Due to this variability and unpredictability, previously recorded revenue adjustments are not indicative of future revenue adjustments from actual cash collections, which may fluctuate significantly.
+Added: Additionally, if coding changes were to occur, payments for certain uses of our tests could be reduced, put on hold, or eliminated.
This variability and unpredictability could increase the risk of future revenue reversal and result in our failing to meet any previously publicly stated guidance we may provide.
−Removed: We perform our tests in our clinical laboratory located in Redwood City, California.
−Removed: Our laboratory is CAP-accredited, CLIA-certified, NYSDOH-permitted and also licensed in California, Florida, Maryland, Pennsylvania and Rhode Island.
−Removed: In February 2022, we received CAP accreditation for our laboratory in Japan where we will commence processing samples following receipt of PMDA approval for our Guardant360 tests.
+Added: We currently perform our tests in our laboratories located in Redwood City, California, and San Diego, California.
+Added: Our Redwood City laboratory is CAP-accredited, CLIA-certified, NYSDOH-permitted, and licensed in California, Florida, Maryland, Pennsylvania and Rhode Island, and also achieved ISO15189 accreditation.
+Added: Our San Diego laboratory is CAP-accredited and CLIA-certified.
+Added: In addition, our Palo Alto, California laboratory is currently operated as a center for our research and technology development.
+Added: In February 2022, we received CAP accreditation for our laboratory in Japan where we expect to commence processing samples following receipt of additional certification for processing IVD samples and reimbursement approval.
The proprietary validated methods utilize robust semi-automated workflows designed for high throughput sample testing.
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All major processing steps utilize quality control to ensure consistent and reproducible results.
−Removed: Guardant Health Digital Sequencing Technology
−Removed: Guardant Health Digital Sequencing Technology combines state-of-the-art technology from multiple disciplines and is enabled by robust, high-efficiency biochemistry at the front-end, next-generation sequencing and a machine learning augmented bioinformatics pipeline.
−Removed: The technology, through machine learning, has accrued performance improvements by incorporating learnings generated from the data collected from additional samples.
We utilize industry leading vendors for our supply chain.
Most reagents and materials are sourced from a limited number of vendors and would require qualification to transition to a different vendor.
−Removed: To mitigate risk, we employ a multi-month, multi-lot safety stock strategy to ensure an uninterrupted supply of reagent and material to our laboratory.
−Removed: In the event that a latent defect is identified, the lot of material in use is expected to be timely
−Removed: quarantined and changed for a new lot that has been previously qualified and released for use.
+Added: To mitigate risk, we employ a multi-month, multi-lot safety stock strategy to ensure an uninterrupted supply of reagent and materials to our laboratories.
+Added: In the event that a latent defect is identified, the lot of material in use is expected to be timely quarantined and changed for a new lot that has been previously qualified and released for use.
The experience with our vendors has provided us confidence in their ability to produce consistent and quality instrumentation, reagents and materials.
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We may also terminate the supply agreement for convenience upon 90 days’ prior written notice.
−Removed: Growing understanding of the importance of biomarkers linked with therapy selection and response is leading to more companies offering services in genomic profiling.
+Added: Growing understanding of the importance of biomarkers linked with therapy selection, response and early screening is leading to more companies offering services in genomic profiling.
The promise of liquid biopsy testing is also leading to more companies attempting to enter the space and compete with us.
Our main competition is from diagnostic companies with products and services to profile genes in cancers based on either single-marker or comprehensive genomic profile testing, based on next-generation sequencing in either blood or tissue.
−Removed: Our competitors within the liquid biopsy space include Foundation Medicine, Inc., which was acquired by Roche Holdings, Inc.
−Removed: in 2018, Roche Molecular Systems, Inc., Thermo Fisher Scientific, Inc., Illumina, Inc., Qiagen N.V., Invitae Corporation, and Sysmex Inostics.
−Removed: In addition, GRAIL, Inc., Natera, Inc., Exact Sciences Corp., and Freenome Holdings, Inc.
−Removed: among others, are our competitors in minimal residual disease testing and early screening testing.
−Removed: 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., as well as companies such as Foundation Medicine, Inc., Caris Life Science, Myriad Genetics, Inc., Tempus Labs, Inc., and NeoGenomics Laboratories, Inc., that sell molecular diagnostic tests for cancer to physicians and have or may develop tests that compete with our tests.
+Added: Our competitors within the liquid biopsy space for therapy selection include Foundation Medicine, Inc., which was acquired by Roche Holdings, Inc.
+Added: Roche Molecular Systems, Inc., Thermo Fisher Scientific, Inc., Illumina, Inc., Qiagen N.V., Invitae Corporation, Caris Life Science, Tempus Labs, Inc., and Agilent Technologies, Inc.
+Added: In addition, NeoGenomics Laboratories, Inc., Natera, Inc., and Exact Sciences Corp., among others, are our competitors in minimal residual disease testing.
+Added: Additionally, our competitors in the early screening testing space include GRAIL, Inc., Exact Sciences Corp., Freenome Holdings, Inc., Delfi Diagnostics and InterVenn Biosciences.
+Added: 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., as well as companies such as Myriad Genetics, 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, 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.
In addition to developing kits, certain diagnostic companies also provide next-generation sequencing platforms that could be used for liquid biopsy testing.
−Removed: These include Illumina, Inc., Thermo Fisher Scientific Inc., and other companies developing next-generation sequencing platforms that are sold directly to biopharmaceutical companies, clinical laboratories and research centers.
+Added: These include Illumina, Inc., Thermo Fisher Scientific Inc., Pacific Biosciences of California, Inc., Ultima Genomics, Inc., Oxford Nanopore Technologies Limited, and other companies developing next-generation sequencing platforms that are sold directly to biopharmaceutical companies, clinical laboratories and research centers.
While many of the applications for these platforms are focused on research and development applications, each of these companies has launched and could continue to commercialize products focused on the clinical oncology market.
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We believe key competitive factors affecting our success are the price and performance of our products, evidence of clinical differentiation, support by KOLs, commercial competitiveness, turnaround time and scope and quality of payer contracts.
−Removed: Our Guardant Health Oncology Platform has developed strengths across five layers, which we believe form a barrier to entry and a competitive advantage.
−Removed: However, we cannot assure that we will continue to compete effectively on each of those layers and our competitive landscape may change over the next few years as a result of new competitors entering through investment and acquisition activity.
+Added: Our competitive landscape may change over the next few years as a result of new competitors entering through investment and acquisition activity.
Intellectual property
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Regulatory framework for medical devices in the United States
−Removed: Pursuant to its authority under the Federal Food, Drug and Cosmetic Act, or the FDCA, the FDA has jurisdiction over medical devices, which are defined to include, among other things, in vitro diagnostic devices, or IVDs.
+Added: Pursuant to its authority under the Federal Food, Drug and Cosmetic Act, or the FDCA, the FDA has jurisdiction over medical devices, which are defined to include, among other things, IVDs.
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.
−Removed: 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 premarket approval application, or PMA.
+Added: 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.
−Removed: 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
−Removed: presents a moderate or low risk.
+Added: 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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In addition, over the last several years, the FDA has proposed reforms to its 510(k) clearance process, and such proposals could include increased requirements for clinical data and a longer review period, or could make it more difficult for manufacturers to utilize the 510(k) clearance process for their products.
−Removed: For example, in November 2018, FDA officials announced steps that the FDA intended to take to modernize the premarket notification pathway under Section 510(k) of the FDCA.
−Removed: Among other things, the FDA announced that it planned to develop proposals to drive manufacturers utilizing the 510(k) pathway toward the use of newer predicates.
−Removed: These proposals included plans to potentially sunset certain older devices that were used as predicates under the 510(k) clearance pathway, and to potentially publish a list of devices that have been cleared on the basis of demonstrated substantial equivalence to predicate devices that are more than 10 years old.
−Removed: These proposals have not yet been finalized or adopted, and the FDA may work with Congress to implement such proposals through legislation.
−Removed: In September 2019, the FDA issued revised final guidance describing an optional “safety and performance based” premarket review pathway for manufacturers of “certain, well-understood device types” to demonstrate substantial equivalence under the 510(k) clearance pathway by showing that such device meets objective safety and performance criteria established by the FDA, thereby obviating the need for manufacturers to compare the safety and performance of their medical devices to specific predicate devices in the clearance process.
+Added: For example, in September 2019, the FDA issued revised final guidance describing an optional “safety and performance based” premarket review pathway for manufacturers of “certain, well-understood device types” to demonstrate substantial equivalence under the 510(k) clearance pathway by showing that such device meets objective safety and performance criteria established by the FDA, thereby obviating the need for manufacturers to compare the safety and performance of their medical devices to specific predicate devices in the clearance process.
The FDA has developed and maintain a list device types appropriate for the “safety and performance based” pathway and continues to develop product-specific guidance documents that identify the performance criteria for each such device type, as well as recommended testing methods, where feasible.
13 unchanged sentences
Overall, the FDA review of a PMA generally takes between one and three years but may take significantly longer.
−Removed: If the FDA evaluation of a PMA is favorable, the FDA will issue either an approval order, or an approvable letter, the latter of which usually contains a number of conditions that must be met in order to secure final approval of the
+Added: If the FDA evaluation of a PMA is favorable, the FDA will issue either an approval order, or an approvable letter, the latter of which usually contains a number of conditions that must be met in order to secure final approval of the PMA.
When and if those conditions have been fulfilled to the satisfaction of the FDA, the agency will issue a PMA approval letter authorizing commercial marketing of the device, subject to the conditions of approval and the limitations established in the approval letter.
21 unchanged sentences
If an IDE application is approved by the FDA and one or more IRBs, human clinical studies 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 the clinical study after obtaining approval for the study by one or more IRBs without separate approval from the FDA, but must still follow abbreviated IDE
−Removed: 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 study after obtaining approval for the study 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 studies support the safety and effectiveness of the device or warrant the continuation of clinical studies.
31 unchanged sentences
The performance characteristics of this product have not been established.” Neither RUO or IUO devices may be used in clinical practice, and such devices cannot be advertised or promoted for clinical or diagnostic purposes.
−Removed: Devices that are intended for RUO or IUO and are properly labeled as RUO or IUO are exempt from compliance with the FDA requirements discussed above, including the approval or clearance and QSR requirements.
+Added: Devices that are intended for RUO or IUO and are properly labeled as RUO or IUO are exempt from compliance with many FDA requirements discussed above, including the approval or clearance and QSR requirements.
A device labeled RUO or IUO but intended to be used diagnostically may be viewed by the FDA as adulterated and misbranded under the FDCA and is subject to FDA enforcement activities.
5 unchanged sentences
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.
−Removed: Our Guardant 360 CDx test has been approved by the FDA for use as a companion diagnostic to identify NSCLC patients who may respond to certain therapies marketed by our biopharmaceutical customers.
+Added: Our Guardant 360 CDx test has been approved by the FDA for use as a companion diagnostic to identify NSCLC and breast cancer patients who may respond to certain therapies marketed by our biopharmaceutical customers.
Pervasive and continuing FDA regulation
39 unchanged sentences
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.
−Removed: Except for (general) in vitro diagnostic medical devices (i.e., all in vitro diagnostic medical devices other than those covered by Annex II to the IVDD and in vitro diagnostic medical devices for self-testing),
−Removed: where the manufacturer can self-declare the conformity of its products with the essential requirements, a conformity assessment procedure requires the intervention of a notified body.
+Added: Except for (general) in vitro diagnostic medical devices (i.e., all in vitro diagnostic medical devices other than those covered by Annex II to the IVDD and in vitro diagnostic medical devices for self-testing), where the manufacturer can self-declare the conformity of its products with the essential requirements, a conformity assessment procedure requires the intervention of a notified body.
Notified bodies are independent organizations designated by EU member states to assess the conformity of devices before being placed on the market.
25 unchanged sentences
This aims at reducing the risk of discrepancies in interpretation across the different European markets.
−Removed: O n October 14, 2021, the European Commission proposed a “progressive” roll-out of the IVDR to prevent
−Removed: disruption in the supply of in vitro diagnostic medical devices.
+Added: O n October 14, 2021, the European Commission proposed a “progressive” roll-out of the IVDR to prevent disruption in the supply of in vitro diagnostic medical devices.
Consequently, if the European Parliament and Council adopt the proposed regulation, the IVDR will fully apply on May 26, 2022 but there will be a tiered system extending the grace period for many devices (depending on their risk classification) before they have to be fully compliant with the regulation.
21 unchanged sentences
The MHRA only registers devices where the manufacturer or their United Kingdom, or UK, Responsible Person has a registered place of business in the UK.
−Removed: Manufacturers based outside the UK need to appoint a UK Responsible Person that has a registered place of business in the UK to register devices with the
−Removed: MHRA in line with the grace periods.
+Added: Manufacturers based outside the UK need to appoint a UK Responsible Person that has a registered place of business in the UK to register devices with the MHRA in line with the grace periods.
By July 1, 2023, in Great Britain, all medical devices will require a UKCA, or UK Conformity Assessed, mark but CE marks issued by EU notified bodies will remain valid until this time.
13 unchanged sentences
Other foreign regulations
−Removed: In February 2021, Guardant Health Japan, an affiliate of the Joint Venture with SoftBank, submitted an application to the MHLW, for regulatory approval of Guardant360 CDx.
+Added: In February 2021, Guardant Health Japan, an affiliate of Guardant AMEA, submitted an application to the MHLW, for regulatory approval of Guardant360 CDx.
In December 2021, the MHLW granted regulatory approval of Guardant360 CDx in patients with advanced solid cancers.
20 unchanged sentences
We must also operate within the bounds of the fraud and abuse laws of the states in which we do business which may apply to items or services reimbursed by non-governmental third-party payers, including private insurers.
−Removed: In addition, the Physician Payments Sunshine Act imposes, among other things, reporting requirements on manufacturers of certain devices, drugs and biologics for certain payments and transfers of value by them and in some cases their distributors to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), certain other health care providers beginning in 2022, and teaching hospitals, as well as ownership and investment interests held by physicians (as defined by the statute) and their immediate family members.
+Added: In addition, the Physician Payments Sunshine Act imposes, among other things, reporting requirements on manufacturers of certain devices, drugs and biologics for certain payments and transfers of value by them and in some cases their distributors to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), certain other health care providers such as physician assistants and nurse practitioners, and teaching hospitals, as well as ownership and investment interests held by physicians (as defined by the statute) and their immediate family members.
Manufacturers must submit reports by the 90th day of each calendar year.
3 unchanged sentences
If any physicians or other healthcare providers or entities with whom we do business is found to be not in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from government-funded healthcare programs.
+Added: In January 2022, we received a civil investigative demand, or CID, from the United States Attorney for the Northern District of California in connection with an investigation under the False Claims Act.
+Added: The CID requests information and documents regarding billing government-funded programs for our panel of genetic tests known as Guardant360.
+Added: We are fully cooperating with the investigation.
+Added: At this time, we are unable to predict the outcome of this investigation.
+Added: See “Commitments and Contingencies – Legal Proceedings” in this Annual Report on Form 10-K for more information.
Data Privacy and Security
−Removed: Under the administrative simplification provisions of the Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, the U.S.
−Removed: Department of Health and Human Services, or HHS, issued regulations that establish uniform standards governing the conduct of certain electronic healthcare transactions and requirements for protecting the privacy and security of protected health information, or PHI, used or disclosed by covered entities.
−Removed: Covered entities and their business associates are subject to HIPAA and HITECH.
−Removed: Because we are a health care provider that electronically transmits health care information to payers, we are a covered entity under HIPAA.
−Removed: Our subcontractors
−Removed: that create, receive, maintain or transmit or otherwise process PHI on our behalf must also comply with HIPAA as business associates thereunder.
−Removed: HIPAA and HITECH include the privacy and security rules, breach notification requirements and electronic transaction standards.
−Removed: The privacy rule covers the use and disclosure of PHI by covered entities and business associates.
−Removed: The privacy rule generally prohibits the use or disclosure of PHI except as permitted under the rule.
−Removed: The rule also sets forth individual patient rights, such as the right to access or amend certain records containing his or her PHI, or to request restrictions on the use or disclosure of his or her PHI.
−Removed: The security rule requires covered entities and business associates to safeguard the confidentiality, integrity, and availability of electronically transmitted or stored PHI by implementing administrative, physical and technical safeguards.
−Removed: Under HITECH’s breach notification rule, a covered entity must notify individuals, the Secretary of the HHS, and in some circumstances, the media of breaches of unsecured PHI.
−Removed: If they are found to be in violation of HIPAA as the result of a breach of unsecured PHI, a complaint about their privacy practices or an audit by HHS, entities may be subject to significant civil and criminal fines and penalties and/or additional reporting and oversight obligations if such entities are required to enter into a resolution agreement and corrective action plan with HHS to settle allegations of HIPAA non-compliance.
−Removed: In addition, we may be subject to state data privacy, security and data breach notification laws, which may govern the collection, use, disclosure and protection of health-related and other personal information.
−Removed: State laws may be more stringent, broader in scope or offer greater individual rights with respect to PHI than HIPAA.
−Removed: California, for example, has enacted the Confidentiality of Medical Information Act, which sets forth standards in addition to HIPAA and HITECH with which all California health care providers like us must abide.
−Removed: Further, laws in all 50 states require businesses to provide notice to individuals whose personally identifiable information has been disclosed as a result of a data breach.
−Removed: The laws are not consistent, and compliance in the event of a widespread data breach is costly.
−Removed: States are also constantly amending existing laws, and creating new data privacy and security laws, requiring attention to frequently changing regulatory requirements.
−Removed: For example, the California Consumer Privacy Act, or the CCPA, went into effect January 1, 2020.
−Removed: The CCPA contains certain disclosure obligations for businesses that collect personal information about California residents and affords those individuals new rights relating to their personal information that may affect our ability to use personal information.
−Removed: The CCPA authorizes private lawsuits to recover statutory damages for certain data breaches.
−Removed: Although the CCPA exempts PHI regulated by HIPAA and certain data regarding clinical studies, the CCPA, to the extent applicable to our business and operations, may increase our compliance costs and potential liability with respect to other personal information we maintain about California residents.
−Removed: Further, the California Privacy Rights Act, or the CPRA, recently passed in California.
−Removed: The CPRA will impose additional data protection obligations on covered businesses, including additional consumer rights processes, limitations on data uses, new audit requirements for higher risk data, and opt outs for certain uses of sensitive data.
−Removed: It will also create a new California data protection agency authorized to issue substantive regulations and could result in increased privacy and information security enforcement.
−Removed: The majority of the provisions will go into effect on January 1, 2023, and additional compliance investment and potential business process changes may be required.
−Removed: Similar laws have passed in Virginia and Colorado, and have been proposed in other states and at the federal level, reflecting a trend toward more stringent privacy legislation in the United States.
−Removed: Complying with these various state laws and regulations, which may differ from state to state, requires significant resources and may complicate our compliance efforts.
−Removed: Failure to comply with these laws, where applicable, can result in the imposition of significant civil and/or criminal penalties and private litigation.
−Removed: Privacy and security laws, regulations, and other obligations are constantly evolving, may conflict with each other to make compliance efforts more challenging, and can result in investigations, proceedings, or actions that lead to significant penalties and restrictions on data processing.
+Added: 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: 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.
+Added: In addition, certain foreign laws govern the privacy and security of personal data, including health-related data.
+Added: 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.
+Added: Cybersecurity
+Added: In the normal course of business, we may collect and store personal information and other sensitive information, including proprietary and confidential business information, trade secrets, intellectual property, information regarding study participants in connection with clinical studies, sensitive third-party information and employee information.
+Added: To protect this information, our existing cybersecurity policies require monitoring and detection programs, network security precautions, encryption of critical data, and management of third party risk.
+Added: We maintain various protections designed to safeguard against cyberattacks, including firewalls and virus detection software.
+Added: We have established and test our disaster recovery plan and we protect against business interruption by backing up our major systems.
+Added: In addition, we periodically scan our environment for any vulnerabilities, perform penetration testing and engage third parties to assess effectiveness of our data security practices.
+Added: In addition, we maintain insurance that includes cybersecurity coverage.
+Added: Our cybersecurity program is led by a team of cybersecurity professionals.
+Added: The program incorporates industry-standard frameworks, policies and practices designed to protect the privacy and security of our sensitive information.
+Added: Our cybersecurity team reports to the full Board of Directors annually on information security and cybersecurity matters, or as needed.
+Added: Our Nominating and Corporate Governance Committee, which is comprised of several members from our Board of Directors, has oversight responsibility for our data security practices and we believe the committee has the requisite skills and visibility into the design and operation of our data security practices to fulfill this responsibility effectively.
+Added: Five members from our Board of Directors have cybersecurity experience, including AmirAli Talasaz, Vijaya Gadde, Meghan Joyce, Samir Kaul and Myrtle Potter.
+Added: Despite the implementation of our cybersecurity program, our security measures cannot guarantee that a significant cyberattack will not occur.
+Added: A successful attack on our information technology systems could have significant consequences to the business.
+Added: While we devote resources to our security measures to protect our systems and information, these measures cannot provide absolute security.
+Added: See “Risk Factors – General Risk Factors” for additional information about the risks to our business associated with a breach or compromise to our information technology systems.
healthcare reform
4 unchanged sentences
On June 17, 2021, the U.S.
−Removed: Supreme Court dismissed the most recent judicial challenge to the ACA brought by several states without specifically ruling
−Removed: on the constitutionality of the ACA.
+Added: Supreme Court dismissed the most recent judicial challenge to the ACA brought by several states without specifically ruling on the constitutionality of the ACA.
Thus, the ACA will remain in effect in its current form.
3 unchanged sentences
In addition, other legislative changes have been proposed and adopted since the ACA was enacted.
−Removed: On August 2, 2011, the Budget Control Act of 2011 was signed into law, which, among other things, reduced Medicare payments to providers by 2% per fiscal year, effective on April 1, 2013 and, due to subsequent legislative amendments to the statute, will remain in effect through 2030, with the exception of a temporary suspension from May 1, 2020 through March 31, 2021, unless additional Congressional action is taken.
+Added: On August 2, 2011, the Budget Control Act of 2011 was signed into law, which, among other things, reduced Medicare payments to providers, effective on April 1, 2013 and, due to subsequent legislative amendments to the statute, will remain in effect through 2032, with the exception of a temporary suspension from May 1, 2020 through March 31, 2022, unless additional Congressional action is taken.
We anticipate there will continue to be proposals by legislators at both the federal and state levels, regulators and commercial payers to reduce costs while expanding individual healthcare benefits.
2 unchanged sentences
Our Employees and Commitment to Diversity, Equity and Inclusion
−Removed: As of December 31, 2021, we had 1,373 full-time employees, of which approximately 1,354 are in the U.S., with the remainder in Europe and Canada.
+Added: As of December 31, 2022, we had 1,793 full-time employees, of which approximately 1,685 are in the U.S., with the remainder in Asia, Europe and Canada.
We have also engaged and may continue to engage independent contractors to assist us with our operations.
12 unchanged sentences
For leadership positions across the company, which is defined as director level and above, 34% self-identified as racially/ethnically diverse and 40% self-identified as women.
−Removed: In 2021, we added two women to our Board of Directors, and as of December 31, 2021, women held 57% of the independent director seats on our Board.
+Added: As of December 31, 2022, women held 50% of the independent director seats on our Board.
Culture, Compensation and Benefits
2 unchanged sentences
Our compensation and benefits team strive to develop and implement policies and programs that support our business goals, maintain competitiveness, promote shared fiscal responsibility among our employees, strategically align talent within our organization and reward performance, while also managing the costs of such policies and programs.
−Removed: In order to ensure that we are meeting our human capital objectives, we frequently utilize employee engagement surveys to understand the effectiveness of our employee development and compensation programs and where we can improve across the company.
−Removed: We regularly evaluate our compensation programs with an independent compensation consultant and utilize industry benchmarking in an effort to ensure they are competitive compared to similar biotechnology and biopharmaceutical companies with which we compete for talent, as well as fair and equitable across our workforce with respect to gender, race and other personal characteristics.
+Added: In order to ensure that we are meeting our human capital objectives, we regularly utilize employee engagement surveys to understand the effectiveness of our employee development and compensation programs and where we can improve across the company.
+Added: We also regularly evaluate our compensation programs with an independent compensation consultant and utilize industry benchmarking in an effort to ensure they are competitive compared to similar biotechnology and biopharmaceutical companies with which we compete for talent, as well as fair and equitable across our workforce with respect to gender, race and other personal characteristics.
We are committed to rewarding, supporting, and developing the employees who make it possible to deliver on our strategy.
To that end, we offer a comprehensive total rewards package that includes market-competitive fixed and/or variable pay, broad-based equity grants and bonuses, access to medical, dental, vision and life insurance benefits, disability coverage, fertility subsidies, retirement savings plans, paid time off and family leave, caregiving support, fitness, cellphone and internet reimbursements, and mental health and other wellness benefits.
−Removed: In recognition of the new challenges the COVID-19 pandemic brought, we took various steps to support our employees, including providing free on-site and at-home COVID-19 tests to our employees, deep cleaning our facilities, providing personal protective equipment to our laboratory and scientific employees, implementing additional safety measures advised by health authorities, restricting business travel and site visitors and implementing remote working for all non-essential laboratory related employees.
−Removed: In addition, we have provided unlimited sick leave for employees who were quarantined, sick or needed to provide care for their families due to COVID-19.
−Removed: Further, despite the impact of the COVID-19 pandemic, we have not cut salaries or hourly rates for any employees.
Available information
5 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.