What changed in this filing

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Item 1. Business

2024-02-22 compared with 2023-02-23 · 72 added, 90 removed, 557 unchanged (23% of the section changed)

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.

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.

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

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

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

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

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

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

We also collaborate with biopharmaceutical companies in clinical studies by providing the above-mentioned tests, as well as the GuardantOMNI blood test for advanced-stage cancer, and the GuardantINFINITY blood test, 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.

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

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

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

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

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

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

In 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.

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

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

The FDA’s Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee intends to review the PMA.

We also expect to expand into lung and multi-cancer screening with our investigational, next-generation Shield assay.

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

▪ using our strategic relationships, including our partnerships with European cancer centers and research organizations, to drive global commercialization of our products.

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

Our products and development program

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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.

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.

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

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

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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.

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.

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.

Our Guardant360 LDT test measures 80+ cancer-related genes and supports new guideline-recommended biomarkers, to help inform which therapy may be effective for advanced stage cancer patients with solid tumors, without the need to obtain archival tissue or subject the patient to another invasive biopsy.

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

Guardant360 Response Test

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.

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

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

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Guardant360 TissueNext Test

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.

To complement our liquid biopsy-based products, Guardant360 TissueNext, our first tissue-based test, 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.

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

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

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

Recurring Monitoring / Minimum Residual Disease

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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.

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

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

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

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.

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

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

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According to American Cancer Society:

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.

Colorectal Cancer Facts & Figures 2023-2025, it is estimated that only 59% of adults at 45 years and older are screened despite compelling evidence that routine cancer screening can reduce colorectal cancer mortality.

Therefore, we believe that there is a critical need to develop products to expand precision oncology to earlier stage cancer settings.

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

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

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

Based on these study results, we plan to complete our premarket approval, or PMA, submission to the FDA in the first quarter of 2023.

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

The FDA’s Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee intends to review the PMA.

We also expect to expand into lung and multi-cancer screening with our investigational, next-generation Shield assay.

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.

The study is anticipated to run in approximately 100 centers in the United States and Europe.

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.

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GuardantOMNI Test

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.

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.

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

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

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.

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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.

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

GuardantINFINITY Test

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GuardantINFORM

In June 2020, we launched GuardantINFORM, our real-world evidence platform featuring an extensive clinical-genomic dataset of advanced cancer patients.

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.

Applications for the GuardantINFORM platform cover research and development, clinical study planning and modelling, and commercial applications.

GuardantINFORM complements our core diagnostic business with aggregated data obtained through real world genomic testing matched with clinically relevant information, which enables important insights into disease progression and treatment impact that can be fed back into drug discovery and development as well as clinical research and practice.

Given the trend for oncologists to use liquid biopsy to monitor changes over time, our GuardantINFORM database uniquely provides longitudinal biological insight to go alongside longitudinal clinical outcomes, which is particularly valuable for a disease characterized by resistance, and for which testing will move earlier and earlier in the cancer journey.

Smart Liquid Biopsy Platform

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Clinical Studies and Publications

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.

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

Such a strategy is predicated on the tests’ 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.

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

We have over 140 targeted therapy outcomes studies, more than 450 peer-reviewed publications and more than 900 scientific abstracts.

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.

Commercialization

Successful commercial adoption of our tests by clinicians and biopharmaceutical companies is critical to our business.

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.

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.

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

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

clinical commercial efforts

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

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

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

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

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• companion diagnostic development to support the approval and commercialization of therapeutics.

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.

We also expect to be able to capture other commercial opportunities from our genomic and epigenomic data, which can be used in combination with clinical outcomes or claims data for multiple applications, including novel target identification.

International commercial efforts and expansion

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We currently offer our tests in countries outside the United States primarily through direct contacts with insurers and hospitals, distributor relationships, and laboratory partnerships.

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.

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

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

We are conducting studies in various jurisdictions and have started efforts to secure reimbursement in several countries.

As these studies progress and we near commercial opportunities there, we are seeking to establish in-country laboratories and direct sales organizations.

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.

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.

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).

In March 2022, MHLW granted regulatory approval of Guardant360® CDx in patients with advanced solid tumors.

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).

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.

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.

Upon our exercise of the call right in November 2021, SoftBank no longer had the option to exercise its put right.

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.

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.

We expect the partnership to help biopharmaceutical companies bring the next generation of cancer therapies to patients in the region.

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

In addition, we have established, and as these studies progress and we near commercial opportunities in these jurisdictions, will continue to seek to establish in-country laboratories and direct sales organizations.

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.

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.

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.

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.

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 digital sequencing platform became available at the VHIO testing facility in Spain.

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

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

In June 2022, we purchased all of the shares held by SoftBank and its affiliates, and upon completion of the transaction, we obtained full control over operations of Guardant AMEA throughout the Asia, Middle East and Africa region.

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

In February 2022, we received accreditation from College of American Pathologists, or CAP, and in October 2022, we received In Vitro Diagnostic, or IVD, sample processing approval from the MHLW for our laboratory in Japan.

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

In June 2022, we signed a strategic partnership agreement with Adicon Holdings Limited, or Adicon, a leading independent clinical laboratory company based in China, and in December 2023, the blood-based cancer testing services based on our digital sequencing platform became available at Adicon's testing facility, which offers our industry-leading comprehensive genomic profiling tests to biopharmaceutical companies to advance clinical research and the development of new cancer therapies in China.

Payer coverage and reimbursement

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

In addition to our existing contracted payers, various laboratory benefit managers and evidence review organizations working with commercial payers have endorsed coverage of our Guardant360 test.

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

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

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

This includes addressing variable coverage requirements and evidence required, and the need for enhanced guideline support.

As we broaden our coverage amongst contracted payers to include additional tests of ours, we may begin to experience increases in average revenue per test performed;

As we broaden our coverage amongst commercial payers to include additional tests of ours, we may begin to experience increases in average revenue per test performed;

however, we cannot make any assurances that we will be successful in broadening our coverage on a timely basis or at all.

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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.

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.

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 took effect on January 1, 2023.

Changes include updated regulatory definitions to specify the data collection period for the data reporting period of January 1, 2023 through March 31, 2023;

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Current Procedural Terminology, or CPT, coding plays a significant role in how our tests are reimbursed both from commercial and governmental payers.

In addition, Z-Code Identifiers are used by certain payers, including under Medicare's MolDx, to supplement CPT codes for our molecular diagnostics tests.

In addition, Z-Code Identifiers are used by certain payers, including under Medicare's Molecular Diagnostic Services Program, or MolDx, to supplement CPT codes for our molecular diagnostics tests.

Changes to the codes used to report to payers may result in significant changes in reimbursement.

If their policies were to change in the future to cover additional cancer indications, we anticipate that our total reimbursement would increase.

In January 2021, a PLA code was issued for our Guardant360 CDx test with an effective date in April 2021.

In January 2021, a proprietary laboratory analyses, or 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.

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.

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.

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

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

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

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

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

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

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

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

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Other Considerations

As of January 2024, 15 states, including California, have enacted laws that require biomarker testing to be covered for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of disease or condition if the test is supported by medical and scientific evidence, and these enacted laws will mandate coverage for our Guardant360 CDx test, Guardant360 LDT test, Guardant360 TissueNext test, Guardant Response test and Guardant Reveal test when certain criteria are met.

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

While we believe that additional states might enact similar laws in the future, we cannot predict how these changes, if any, will affect our business and financial condition.

Where we are not reimbursed in full or at all, we may elect to appeal the insurer’s underpayment or denial of payment or seek payment from the patient.

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We currently perform our tests in our laboratories located in Redwood City, California, and San Diego, California.

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.

Our San Diego laboratory is CAP-accredited and CLIA-certified.

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

Our San Diego laboratory is CAP-accredited, CLIA-certified and licensed in California.

In addition, our Palo Alto, California laboratory is currently operated as a center for our research and technology development.

We have also received CAP accreditation and IVD sample processing approval from the MHLW for our laboratory in Japan.

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

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

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.

In addition, NeoGenomics Laboratories, Inc., Natera, Inc., and Exact Sciences Corp., among others, are our competitors in minimal residual disease testing.

Roche Molecular Systems, Inc., Thermo Fisher Scientific, Inc., Illumina, Inc., Qiagen N.V., Invitae Corporation, Caris Life Science, and Tempus Labs, Inc.

In addition, NeoGenomics Laboratories, Inc., Natera, Inc., Exact Sciences Corp., and Tempus Labs, Inc., among others, are our competitors in minimal residual disease testing.

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

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.

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 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.

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We seek to ensure that investments made into the development of our technology are protected by relying on a combination of patents, trademarks, copyrights, trade secrets (such as know-how), license agreements, confidentiality agreements and procedures, non-disclosure agreements, invention disclosure and assignment agreements and other contractual rights and obligations.

Our patent strategy is focused on seeking coverage for our core technology, our digital sequencing platform, and specific follow-on applications and implementations for detecting and monitoring cancer or other diseases by determining genetic variations in patient samples.

In addition, we file for patent protection in connection with our on-going research and development activities, particularly those related to early-stage cancer detection, including those based on pattern recognition based on analyzing our extensive patient blood sample database, among others.

Our patent strategy is focused on seeking coverage for our core technology, our digital sequencing platform, and specific follow-on applications and implementations for screening, detecting and monitoring cancer or other diseases by determining genetic and/or epigenomic variations in patient samples.

In addition, we file for patent protection in connection with our on-going research and development activities, particularly those related to early-stage cancer detection.

Our patent portfolio includes owned and licensed patents and patent applications, generally falling into three broad categories:

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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.

Manufacturers may choose to use the UKCA mark on a voluntary basis until June 30, 2023.

However, UKCA marking will not be recognized in the EU.

Effective July 1, 2023, in Great Britain, all medical devices require a UKCA, or UK Conformity Assessed mark.

The rules for placing medical devices on the market in Northern Ireland, which is part of the UK, differ from those in the rest of the UK.

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MHRA seeks to amend the UK Medical Devices Regulations 2002 (which are based on EU legislation, primarily the EU Medical Devices Directive 93/42/EEC and the IVDD), in particular to create a new access pathways to support innovation, create an innovative framework for regulating software and artificial intelligence, or AI, as medical devices, reform IVD regulation, and foster sustainability through the reuse and remanufacture of medical devices.

The regime is expected to come into force in July 2023, coinciding with the end of the acceptance period for EU CE marks in Great Britain, subject to appropriate transitional arrangements.

The regime came into force in July 2023, coinciding with the end of the acceptance period for EU CE marks in Great Britain, subject to appropriate transitional arrangements.

The consultation indicated that the MHRA will publish guidance in relation to the changes to the regulatory framework and may rely more heavily on guidance to add flexibility to the regime.

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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.

Cybersecurity

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.

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.

We maintain various protections designed to safeguard against cyberattacks, including firewalls and virus detection software.

We have established and test our disaster recovery plan and we protect against business interruption by backing up our major systems.

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.

In addition, we maintain insurance that includes cybersecurity coverage.

Our cybersecurity program is led by a team of cybersecurity professionals.

The program incorporates industry-standard frameworks, policies and practices designed to protect the privacy and security of our sensitive information.

Our cybersecurity team reports to the full Board of Directors annually on information security and cybersecurity matters, or as needed.

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.

Five members from our Board of Directors have cybersecurity experience, including AmirAli Talasaz, Vijaya Gadde, Meghan Joyce, Samir Kaul and Myrtle Potter.

Despite the implementation of our cybersecurity program, our security measures cannot guarantee that a significant cyberattack will not occur.

A successful attack on our information technology systems could have significant consequences to the business.

While we devote resources to our security measures to protect our systems and information, these measures cannot provide absolute security.

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

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In addition, other legislative changes have been proposed and adopted since the ACA was enacted.

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.

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Our Employees and Commitment to Diversity, Equity and Inclusion

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.

As of December 31, 2023, we had 1,779 employees, 1,768 of which are full-time employees and approximately 1,655 of which 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.

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Our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, including their exhibits, proxy and information statements, and amendments to those reports filed or furnished pursuant to Sections 13(a), 14, and 15(d) of the Securities Exchange Act of 1934, as amended, are available through the “Investors” portion of our website free of charge as soon as reasonably practicable after we electronically file such material with, or furnish it to, the SEC.

We use the “Investors” portion of our website for purposes of compliance with Regulation FD and as a routine channel for distribution of important information to investors and interested parties, including new releases, analyst presentations, financial information and corporate governance practices.

Accordingly, you should monitor the “Investors” portion of our website for the release of this information.

Information on our website is not part of this Annual Report on Form 10-K or any of our other securities filings unless specifically incorporated herein by reference.

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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.

What changed 10-K

Item 1. Business