Frequently Asked Questions

Veracyte is headquartered in South San Francisco, California, with offices in San Diego as well as Austin, Texas, and Haifa, Israel.

Veracyte offers laboratory developed tests (LDTs) performed in our CLIA-certified, high-complexity labs for three cancer types: thyroid, prostate, and bladder.

The Prosigna Breast Cancer Prognostic Gene Signature Assay is available as a CE-IVD test outside the US. To find out if Prosigna is available in your country or for information about reimbursement and insurance coverage, contact us at [email protected].

Our tests provide clinicians with insights based on each patient’s unique tumor biology to help guide personalized treatment decisions. To learn more, visit Technology and Pipeline.

Investors can trade Veracyte publicly on the Nasdaq Global Market under the ticker symbol VCYT. The company went public in October 2013.

In the United States, healthcare providers order Veracyte tests. Patients cannot order tests directly. A healthcare provider must order them as part of clinical cancer care.

For our in vitro diagnostic (IVD) tests, global healthcare providers or local hospital labs order these tests. Patients cannot order IVDs directly.

We work to make our laboratory developed tests (LDTs) accessible to patients. Medicare and many commercial insurance plans cover our molecular tests in the United States. We also offer billing support, financial assistance, and flexible payment options. Some restrictions apply.

We share whole-genome data with researchers through our GRID database and research partnerships. This helps advance discoveries in prostate, bladder, and thyroid cancers. We partner with clinicians, academic institutions, and research groups worldwide.

The VDP is our ever-expanding platform for cancer test development, validation and continued innovation. It uniquely integrates whole-ome data from every test we perform, real-world and other clinical data, along with our world-class AI capabilities to help advance scientific understanding of cancer and advance new opportunities to improve patient care.

Our MRD approach is unique because we perform whole-genome testing at every step—from the initial test to determine a tumor’s unique molecular fingerprint to then looking for that same molecular fingerprint in the patient’s blood samples over time to indicate whether or not the cancer has returned. We believe this approach enables us to provide a more efficient and effective test in the near term and also generates robust data that will allow us to partner with the research community to unlock new cancer insights that can further advance patient care.

We are continuing to advance our digital pathology capabilities and research to assess how this technology can complement and potentially enhance our molecular testing capabilities. In addition, we are sharing our digital pathology services and associated AI models with research collaborators to further the science in the field of combined AI-based imaging and molecular analysis.

“Whole-ome” describes the approach we take at Veracyte to broad molecular profiling, which can include genomic and transcriptomic data to build a comprehensive view of tumor biology.

Our whole-genome approach provides high sensitivity and specificity, requires less blood, and can provide greater insights about each patient’s cancer status.

Our platform is whole genome every step of the way, which represents a fundamental shift from traditional MRD methods. This captures the full mutational spectrum unique to each patient’s cancer, providing broader detection capability and reducing the risk of missed variants. The TrueMRD platform combines whole-genome sequencing with proprietary AI algorithms to create personalized signatures that enable more accurate and timely cancer monitoring.

Multiple peer-reviewed published studies demonstrate the performance and value of our whole-genome TrueMRD platform’s approach—leading to its exclusive selection by Gustave Roussy for use in the multi-cancer UMBRELLA trial. Strong clinical validation data for our MRD platform in muscle-invasive bladder cancer was published in European Urology, demonstrating its high sensitivity and specificity, and ability to characterize genomic changes to a patient’s cancer over time.

Our TrueMRD platform analyzes the entire tumor genetic landscape rather than a limited set of mutations at every step, providing broader detection capability and reducing the risk of missing cancer variants not covered by targeted panels.

Clinicians can place an order by using the Decipher provider ordering portal or by filling out a requisition and submitting the required forms via email or fax. Should you need any assistance with ordering, please speak with your local representative or contact us here for support.

Please fill out our contact us form and a representative will reach out to help you set up an account.

We are committed to ensuring access to all eligible patients. Click here for more information regarding Decipher Prostate billing and insurance coverage.

For questions related to billing and insurance, please contact us here.

The Decipher Prostate Genomic Classifier is available as part of Veracyte’s Clinical Laboratory Improvement Amendments (CLIA)-validated laboratory developed test (LDT) service. FDA approval or clearance is not required for the Decipher Prostate test.

Veracyte Labs SD, which performs Decipher testing, is accredited/licensed by the following:

• College of American Pathologists
• Centers for Medicare and Medicaid Services (CMS) CLIA
• California Department of Public Health
• New York State Department of Health
• Pennsylvania Department of Health
• State of Rhode Island and Providence Plantations Department of Health Center for Health Facilities Regulation
• Maryland Department of Health, Office of Health Care Quality

Currently, the Decipher Prostate test is only available to patients within the United States through Veracyte’s CLIA-validated laboratory service. We are actively exploring opportunities to expand access to Decipher testing internationally in the coming years. If you are located outside the US and are interested in Decipher testing, please fill out our contact us form to let us know.

Decipher Prostate provides genomic risk information that helps tailor treatment intensity across the prostate cancer continuum, supporting both escalation and de-escalation strategies. It can help:

• Guide intensity and frequency of active surveillance follow-up
• Inform selection between surveillance, focal therapy, or definitive local treatment
• Assess whether radiation therapy (RT) alone is sufficient or should be combined with androgen deprivation therapy (ADT)
• Inform optimal duration of ADT when used with primary RT
• Guide timing and intensity of adjuvant or salvage therapy after radical prostatectomy (RP)
• Identify patients who may benefit from treatment intensification with AR pathway inhibitors (ARPIs) or chemotherapy