Veracyte Profile
Veracyte, Inc. (Veracyte), together with its consolidated subsidiaries, operates as a global diagnostics company that empowers clinicians with the high-value insights they need to guide and assure patients at pivotal moments in the race to diagnose and treat cancer.
The company's high-performing tests enable clinicians to make more confident diagnostic, prognostic and treatment decisions, helping patients avoid unnecessary procedures and interventions, and accelerating time to appropriate treatment, thereby improving outcomes for patients all over the world. With the company's acquisition of C2i, a minimal residual disease, or MRD, detection company, which was completed in February 2024, the company intends to expand its role across the cancer continuum, moving from providing early decision support to following the patient through treatment, helping to monitor the success of a therapeutic or surgical intervention, and supporting the determination of the best course of action for each patient.
Through the company's leading portfolio of comprehensive molecular diagnostic tests, the company is focused on progressing patient care from the current standard to a more individualized approach, leveraging each patient's unique cancer biology to improve their outcomes.
The company offers tests in thyroid cancer (Afirma); prostate cancer (Decipher Prostate); breast cancer (Prosigna); bladder cancer (Decipher Bladder); and interstitial lung diseases (Envisia). The company's novel Percepta Nasal Swab test for lung cancer is being run in the company's Clinical Laboratory Improvement Amendments of 1988, or CLIA, laboratory in the support of clinical studies and the company's test for lymphoma is in development as a companion diagnostic.
The company serves global markets with two complementary models. In the United States, the company offers laboratory developed tests, or LDTs, through the company's centralized CLIA certified laboratories in South San Francisco and San Diego, California, supported by the company's cytopathology expertise in Austin, Texas. Additionally, primarily outside of the United States, the company provides tests to patients as in vitro diagnostics, or IVDs, which are distributed to laboratories and hospitals that can perform the tests locally. The company's Prosigna test is available as an IVD and the company's Decipher Prostate and Percepta Nasal Swab tests are in development as IVDs. The company is using a multi-platform IVD approach, which will include next generation sequencing, or NGS, and quantitative polymerase chain reaction, or qPCR, to accelerate the company's ability to reach patients globally with the company's tests.
Novel Approach - the Veracyte Diagnostics Platform
The company has established a novel approach to drive the successful launch and adoption of the company's high-performing tests, which the company refers to as the Veracyte Diagnostics Platform. This approach leverages broad genomic and clinical data, the company's deep bioinformatics and artificial intelligence, or AI, capabilities, and a powerful evidence-generation engine, which ultimately drives durable reimbursement and guideline inclusion for the company's tests, along with new insights to support continued innovation and pipeline development.
The company's high performing tests are developed using this proven framework. The company identifies an unmet clinical need, determine the combination of appropriate biomarkers utilizing cutting-edge genomic and other technologies, and then tune the company's assays with deep scientific and machine learning capabilities.
The company then takes a comprehensive approach to launching and driving adoption for the company's tests. The company generates extensive genomic and clinical data through the company's whole-omic approach, fueling insights, evidence and, ultimately, further utility. The company takes a whole-transcriptome approach to the company's diagnostic, prognostic and predictive tests. C2i Genomic's MRD technology will add a whole-genome approach for treatment effectiveness, monitoring, and disease recurrence detection.
In each case, this data is used to develop a comprehensive and robust assay to address a clinical need. The company performs these tests in its clinical labs to generate a growing repository of data. The company then utilizes its deep bioinformatic and AI capabilities to derive broad insights that not only support the test in question, but also enable research to demonstrate expanded test utility or support entry into new indications.
The company's experienced clinical and medical teams work with its scientific and commercial teams to drive repeated cycles of evidence development. With both prospective and retrospective studies over time, the company focuses on evidence that allows the company to answer key clinical questions while also demonstrating the clinical benefit and impact of the company's tests, which is needed to drive their adoption and guideline inclusion.
With the company's years of experience in market access and reimbursement, the company work closely with public and private payers to leverage this evidence and meet their clinical utility requirements, which facilitates reimbursement. The company's market-leading, real-world utilization then continues to drive more data, which leads to more insights, more evidence and more utility, all of which provide additional support for and confidence in the company's tests, further increasing durable reimbursement and guideline inclusion for the company's tests, along with new insights to support continued innovation and pipeline development.
Serving the U.S. Market Through The company's CLIA Labs
In the United States, the company's tests are improving patient care in thyroid, prostate, lung, and bladder cancer, as well as in interstitial lung disease.
All of the company's tests are serviced through the company's own CLIA certified laboratories in South San Francisco and San Diego, California; and Austin, Texas. The company manage the company's labs with a focus on operational excellence and continuous improvement. The company measures performance using such criteria as lab-processing turnaround time, failure rates and deviation vs. control. The company has an active monitoring program to ensure lab operations exceed regulatory requirements. The company uses a systematic, analytical approach aimed at delivering optimal outcomes for patients and referring physicians, while driving lab-efficiency improvement as the company scales operations.
Clinical Diagnostic Tests Offered Through the company's CLIA Labs
Thyroid Cancer - Afirma Genomic Sequencing Classifier
The company developed the Afirma Genomic Sequencing Classifier, or GSC, to determine which patients with indeterminate results are actually benign so that these patients may avoid unnecessary, costly surgery that often leads to the need for lifelong daily thyroid hormone replacement therapy. The test was developed with whole-transcriptome RNA sequencing and machine learning technology to provide physicians with clinically actionable results from the same FNA biopsy used for initial cytopathology. Afirma GSC testing also provides important gene mutation information to help guide treatment decisions for patients with thyroid nodules that are suspicious for cancer.
The company's sales team sells Afirma GSC to endocrinologists and other physicians who perform FNA biopsies on patients with thyroid nodules. Physicians can order Afirma GSC testing in one of two ways: by submitting indeterminate FNA samples directly to Veracyte for genomic testing or by submitting FNA samples for initial cytopathology analysis by the company's partner, Thyroid Cytopathology Partners, with genomic testing performed by Veracyte when the cytopathology is indeterminate. The company's online portal enables physicians and their staff to easily submit and track test orders and download results.
Prostate Cancer - Decipher Prostate Biopsy and Radical Prostatectomy, or RP, Genomic Classifiers
The Decipher Prostate Genomic Classifier test results dramatically improve the physician's ability to personalize therapy for each patient and make more appropriate treatment decisions.
The Decipher Prostate cancer tests, developed through whole-transcriptome analysis and machine learning, are used across localized disease to predict a patient's risk of progressing to metastatic disease within five years, which helps physicians determine an appropriate treatment plan. The Decipher Prostate Biopsy test is performed on a prostate biopsy sample following a cancer diagnosis to inform whether the patient is a candidate for active surveillance, needs monotherapy or may benefit from multi-modal or intensified therapy. The Decipher Prostate RP test is performed on surgical tissue to guide decision-making regarding treatment timing following radical prostatectomy and to help determine whether patients undergoing salvage radiotherapy may benefit from the addition of hormone therapy or may safely avoid hormone therapy and its side effects.
The Decipher Prostate Genomic Classifier is being investigated in seven National Cancer Institute-sponsored, phase 3, prospective, randomized controlled clinical trials; 24 phase 2/3 prospective trials; and more than 20 retrospective studies of phase 3 randomized controlled trials. Many of these trials require Decipher Prostate testing for study inclusion. The test's performance and utility has been evaluated in more than 75 peer-reviewed, published studies and an additional 73 discovery publications leveraging the research-use-only Decipher GRID.
Bladder Cancer - Decipher Bladder Genomic Classifier
Decipher Bladder is a genomic test that measures the molecular profile of bladder cancer using gene expression analysis from transurethral resected bladder tumor specimens. The test was developed for use in bladder cancer patients with high-grade non-muscle-invasive disease who are being considered for treatment and patients with muscle-invasive disease who face the question of immediate cystectomy or systemic treatment in the neoadjuvant setting prior to cystectomy. Decipher Bladder reports the molecular subtype of the tumor specimen as Luminal or Non-Luminal (Luminal Infiltrated, Basal, Basal Claudin-Low or Neuroendocrine-like), with each subtype having distinct biological composition, clinical behavior and predicted benefit from NAC, and may have implications for future therapeutic strategies.
The Decipher Bladder test is supported by multiple peer-reviewed clinical studies demonstrating its ability to identify which patients have a higher risk of upstaging to non-organ confined disease at surgery and which patients may benefit the most from neoadjuvant therapy.
The company began commercialization of the Decipher Bladder test in the fall of 2021, following final Medicare coverage for the test in July 2021. The Decipher Bladder test is the first genomic test to be covered by Medicare for patients with bladder cancer.
ILD/IPF - Envisia Genomic Classifier
The Envisia classifier is the first test of its kind for improving the diagnosis of ILDs, including IPF, without the need for surgery. The test identifies UIP with high accuracy on patient samples that are obtained through transbronchial biopsy, a nonsurgical procedure that is commonly used in lung evaluation.
The Envisia classifier is supported by clinical data published in multiple peer-reviewed journals, including The Lancet Respiratory Medicine and American Journal of Respiratory and Critical Care Medicine. In 2022, an updated global (ATS/ERS/JRS/ALAT) clinical practice guideline highlighted the role of the Envisia Classifier in the diagnosis of IPF with more than 40% of the guideline authors voting to recommend Envisia testing. The guideline points to a published meta-analysis in AnnalsATS demonstrating the Envisia test's consistently high specificity of 92% across 4 separate studies.
The company obtained Medicare coverage for the Envisia classifier through the Molecular Diagnostics Services Program, or MolDX, program in 2019. The company estimates that half of the patients evaluated for ILDs/IPF in the United States are covered by Medicare.
Lung Cancer - Percepta Nasal Swab Test
The company developed the noninvasive Percepta Nasal Swab test to help physicians more accurately, quickly and confidently determine lung cancer risk so that patients whose lung nodules are benign may avoid unnecessary invasive procedures and patients whose nodules are likely cancerous may proceed to further diagnostic work-up and, if necessary, treatment.
The Percepta Nasal Swab test is built upon foundational 'field of injury' science, through which genomic changes associated with lung cancer in current and former smokers are detected using a sample collected non-invasively from the nasal passage. Veracyte developed the final classifier using RNA whole-transcriptome sequencing and machine learning on a training set of nasal samples from more than 1,100 patients representing a wide range of lung and tumor biology.
The company is running the Percepta Nasal Swab test in its CLIA lab in the support of its NIGHTINGALE clinical utility study, in an effort to produce data to help drive Medicare and private payer coverage, as well as clinical adoption.
Driving Global Growth with Distributed IVD Tests
Once the company has developed robust clinical evidence and physician adoption of the company's tests in the United States, the company typically then drives further patient access by launching them, as appropriate, into global markets as IVD tests. This approach enables the company's tests to be performed locally in laboratories and hospitals worldwide, which facilitates market access and physician adoption in Europe and other strategic global markets.
The company offers IVD testing in breast cancer using the nCounter Analysis System, for which the company acquired the exclusive worldwide license for clinical IVD test use in December 2019. In November 2023, the company announced a multi-year agreement with Illumina, Inc. to develop and offer some of the company's molecular tests as decentralized IVD tests on their NextSeq 550Dx NGS instrument to leverage their large installed base and lower cost per test. This agreement reflects the company's expanded, multi-platform approach to IVD testing, which will include NGS and qPCR, to help accelerate the company's ability to make its tests available to more patients globally. The first tests that the company plans to develop for the Illumina NextSeq 550Dx instrument are the company's Prosigna Breast Cancer Assay and Percepta Nasal Swab test, which the company expects to be available for commercialization outside of the United States in 2025 and 2026, respectively. The company is also developing itss Decipher Prostate test as a qPCR-based test, which the company expects to commercialize outside of the United States in the second half of 2025.
The company's acquisition of HalioDx in August 2021 provided the company with a European headquarters to develop, manufacture and supply the company's own IVD test kits. The company has largely completed the transition of the company's test manufacturing from NanoString in the United States to the company's facility in Marseille, France, giving the company greater control of its IVD test supply chain. The vertical integration of development and manufacturing will enhance the company's ability to efficiently serve the global market with a broad menu of diagnostic tests.
Breast Cancer - Prosigna Breast Cancer Assay
The Prosigna Breast Cancer Assay is a clinically validated prognostic assay that uses advanced genomic technology and combines clinical and pathological information to help inform next steps for post-menopausal women with early-stage, hormone receptor positive breast cancer, helping them avoid unnecessary toxic chemotherapy or under-treatment. The assay is performed in laboratories in Europe and the United States, as well as select other countries. The Prosigna Breast Cancer Assay analyzes the activity of 46 genes in the PAM50 gene signature, and based on molecular subtypes, proliferation score, and clinical-pathological features, can provide a hormone-receptor positive, early-stage breast cancer patient and their physician with a prognostic risk-of-recurrence score that indicates the probability of cancer recurrence over the next ten years.
The Prosigna assay is clinically validated in studies published in Annals of Oncology and the Journal of Clinical Oncology. Medicare coverage for Prosigna has been in effect since 2015. The test is recommended in guidelines from the National Comprehensive Cancer Network and the American Society of Clinical Oncology in the United States. Outside of the United States, the test is included in leading medical guidelines, including from the National Institute for Health and Care Excellence in the United Kingdom and the European Society for Medical Oncology.
The Prosigna assay utilizes formalin-fixed and paraffin-embedded breast cancer tissue and is offered as an IVD test that runs on the nCounter Analysis System. The test has been CE-IVD marked, showing that it conforms with European Union regulations, and is available for use by healthcare professionals in the European Union and other countries that recognize the CE mark, as well as in Canada, Israel, Australia, New Zealand and Hong Kong. The Prosigna test is FDA 510(k) cleared in the United States for use on the nCounter Analysis System.
The Prosigna Breast Cancer Assay is sold to laboratories by the company's direct sales team and through distributors in certain countries.
Expanding Into Minimal Residual Disease
In February 2024, the company acquired C2i, an MRD company, adding whole-genome MRD capabilities to the company's novel diagnostics platform and positioning the company to serve physicians and their patients further along the care continuum, in combination with the company's diagnostic and prognostic tests. MRD is a large emerging market, estimated at a total addressable market, or TAM, of $20 billion annually. The company can leverage its specialist commercial channels and relationships to partner early in a patient's care, using the company's indication-specific focus and expertise to drive adoption from the first diagnostic test onward. MRD testing will expand the value the company provides to clinicians to inform whether a patient's intervention was successful or if management escalation is required.
C2i's whole-genome, artificial intelligence-powered approach generates broad signatures from blood more quickly and efficiently than bespoke panels. C2i's MRD solution requires less than a tube of blood (as little as 3-4 ml blood, or 1-2 ml plasma), can go from sample to result in just two weeks, and delivers improved performance compared to imaging and other molecular tests. This ability will enable physicians to track a tumor's progression as it evolves from early diagnosis through patient treatment and follow-up.
The company expects its first application of C2i's technology will be a muscle-invasive bladder cancer MRD test, where the company plans to leverage its strong urology commercial channel and a clear pathway to expected reimbursement. The company expects to launch its first test in the first half of 2026. The company plans to also develop further MRD tests in several other indications.
Biopharmaceutical and Other Revenue
The company has formed numerous biopharmaceutical partnerships that derive value out of the company's assets or future ones. Through development and commercialization of the company's tests, the company has built or gained access to unique biorepositories that include extensive clinical cohorts and whole-genome RNA sequencing and other data.
Through the acquisition of HalioDx in 2021, the company gained expertise in immuno-oncology services for biopharmaceutical customers, as well as know-how in IVD test development and manufacturing, the latter of which is utilized to provide services to other diagnostic companies in indications that are noncompetitive to Veracyte.
Patents and Proprietary Technology
Certain of the company's issued patents expire between 2024 and 2038 and are related to methods used in thyroid cancer diagnostics, urologic cancers diagnostics, lung cancer and disease diagnostics, breast cancer diagnostics, and immuno-oncology diagnostics.
The company holds or in-licenses registered trademarks in the United States for 'Veracyte,' 'Afirma,' 'Percepta,' 'Envisia,' 'Prosigna,' 'Lymphmark,' 'Decipher,' 'GRID,' 'HalioDx,' 'Immunoscore,' 'Brightplex,' 'Immunosign,' 'TMExplore,' and the Veracyte logo. 'C2i Genomics,' 'C2Inform,' and 'C2Intelligence' are trademarks acquired through the C2i acquisition and are pending registration with the USPTO. The company also holds registered trademarks in various jurisdictions outside of the United States.
Veracyte, Afirma, Percepta, Envisia, Prosigna, Lymphmark, Decipher, GRID, HalioDx, TMExplore, Brightplex, Immunosign, C2i Genomics, C2intelligence, C2inform and the Veracyte logo are registered or pending trademarks of Veracyte and its subsidiaries in the United States and selected countries. nCounter is the registered trademark of NanoString Technologies, Inc., or NanoString, in the United States and selected countries and used by Veracyte under license. Immunoscore is the registered trademark of Institut National de la Santé et de la Recherche Médicale, or Inserm, in the United States and selected countries and used by Veracyte under license.
Regulation
The company is subject to CLIA, a federal law that regulates clinical laboratories that test specimens derived from humans for the purpose of providing information for the diagnosis, prevention or treatment of disease. Under CLIA, which is administered by CMS, the company is required to hold a certificate applicable to the type of laboratory examinations and tests the company performs and to comply with standards covering personnel qualifications, facilities administration, quality systems, inspections, and proficiency testing. The company must maintain CLIA compliance and certification to sell the company's tests and be eligible to bill state and federal healthcare programs, as well as many private third-party payers.
In the company's FDA registration, the company has listed the containers the company provides for collection and transport of Afirma GSC and Envisia samples from a physician to the company's clinical reference laboratory as Class I devices in accordance with the classification of regulation for the specimen transport and storage container.
Under the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, the United States Department of Health and Human Services, or HHS, has issued regulations to protect the privacy and security of protected health information used or disclosed by covered entities, which include health care providers, such as the company. HIPAA also regulates standardization of data content, codes and formats used in health care transactions and standardization of identifiers for health plans and providers. In 2009, Congress amended HIPAA through the Health Information Technology for Economic and Clinical Health Act, or HITECH. The implementing regulations of HIPAA, as amended by HITECH, were last modified in 2013 and resulted in significant changes to the privacy, security, breach notification, and enforcement requirements with which the company must comply. Among these changes, covered entities are now vicariously liable for violations of HIPAA resulting from acts or omissions of their business associates where the business associate is an agent of the covered entity and was acting within the scope of its agency, regardless of whether the covered entity and business associate entered into a business associate agreement in compliance with HIPAA.
The company has developed and implemented policies and procedures designed to comply with HIPAA's privacy, security, and breach notification requirements.
In addition to federal privacy regulations, there are a number of state laws governing confidentiality of health information that are applicable to the company's business. In particular, the company is subject to the California Confidentiality of Medical Information Act, which is similar to but in some ways more restrictive than the HIPAA regulations, and the California Consumer Privacy Act, or CCPA, which was enacted in California in 2018 and substantially amended and expanded thereafter, most significantly by a ballot initiative adopted in November 2020 that enacted the California Privacy Rights Act. The California Privacy Rights Act amends and substantially expands the CCPA.
The company is subject to the federal physician self-referral prohibitions, commonly known as the Stark Law, and to similar restrictions under the self-referral prohibitions of certain states in which the company operates, including California's Physician Ownership and Referral Act, or PORA. The company is in compliance with the Anti-kickback Statute, Section 650, and Section 14107.2. The company is in compliance with the PAMA reporting requirements.
Competition
The company's Afirma test faces competition from companies that use next generation sequencing technology or other methods to measure mutational markers such as BRAF and KRAS, along with numerous other mutations. These organizations include, for example, Interpace Diagnostics Group, Inc. and CBLPath, Inc./University of Pittsburgh Medical Center.
The company's Decipher Prostate test faces competition from Myriad Genetics, Inc., or Myriad Genetics, and MDxHealth, SA, or MDxHealth, which offer genomic testing for prognostic purposes within localized prostate cancer.
In general, the company also faces competition from commercial laboratories, such as Laboratory Corporation of America Holdings, Quest Diagnostics, and Sonic Healthcare USA.
History
The company was incorporated in 2006 in Delaware. It was formerly known as Calderome, Inc. and changed its name to Veracyte, Inc. in 2008.
