Veracyte Debuts Prosigna Breast Test in the U.S.

Veracyte Inc. has begun the U.S. launch of its Prosigna Breast Risk of Recurrence (ROR) test, a genomic assay for patients diagnosed with early-stage hormone-receptor positive (HR+) breast cancer. The Prosigna test determines a patient’s ROR score and estimates the 10-year probability of distant recurrence, providing prognostic insight into the way a patient’s cancer may behave over time.

The test’s insights help guide treatment decisions, including predicting whether high-risk patients are likely to benefit from chemotherapy or may safely achieve optimal outcomes with endocrine therapy alone, enabling clinicians to make personalized patient care plans.

“Every patient diagnosed with breast cancer deserves answers they can trust about what their cancer means and what comes next,” Veracyte Chief Commercial Officer John Leite, Ph.D., said​. “Prosigna gives patients and their oncologists a deeper understanding of their individual risk of recurrence, and, for many, whether chemotherapy will truly benefit them or whether they can safely avoid it. That kind of personalized insight can bring greater confidence and reassurance as patients navigate decisions that will shape their care and future health.”

More than 225,000 new HR+/HER2- breast cancer cases are diagnosed annually in the United States. When breast cancer is diagnosed early and treated appropriately, five-year survival rates reach 92%.¹ It is critically important to accurately determine a patient’s risk of recurrence because the effects of treatment escalation or de-escalation have a lasting impact on a patient’s life.

The Prosigna test is the only breast cancer test that factors a patient’s biological, clinical, and pathological information into a single comprehensive analysis. The test uniquely combines intrinsic subtypes and proliferation score with clinical factors to determine a patient’s ROR score and predict the 10-year probability of distant recurrence. This long-term risk assessment provides clinically meaningful insight beyond initial diagnosis, particularly in early-stage breast cancer where recurrence can occur many years later.

“Patients diagnosed with early-stage breast cancer deserve access to the most advanced testing available, with the most up-to-date evidence, so they can make informed treatment decisions with their medical oncology team,” stated Jean Sachs, CEO of Living Beyond Breast Cancer. “Prosigna’s ability to accurately predict risk of recurrence means patients may have the option to avoid chemotherapy and its significant side effects or confidently pursue more aggressive treatment when it will truly benefit them. That is what we want for everyone diagnosed with breast cancer—a personalized treatment plan that is informed by the most up-to-date data.”

For decades, clinical risk factors have been a key factor in treatment decisions. Currently, for many patients with high-risk breast cancer who are premenopausal and node-positive, the standard of care is still chemotherapy and endocrine therapy. New data from the OPTIMA trial show that nodal involvement and other clinical risk factors do not automatically equate to a high risk of recurrence—for the first time, more than two-thirds of node-positive patients who previously might have received chemotherapy can now safely avoid it based on the Prosigna test results.

The Prosigna test differs from other assays due to its:

• Comprehensive molecular analysis: The Prosigna test was developed from the PAM50 genomic classifier, a foundation for understanding breast cancer biology, which classifies a patient’s individual tumor into one of the four intrinsic subtypes. Prosigna is the only test that combines intrinsic subtypes and proliferation score with clinical-pathological factors to provide a comprehensive 10-year probability of distant recurrence.
• Proven ability across high-risk populations: Prosigna is the only test proven to be predictive for chemotherapy benefit decisions in a phase III prospective trial for premenopausal and postmenopausal women with high-risk breast cancer, including those with extensive nodal involvement (up to nine positive nodes).
• Superior prognostic accuracy: Extensively validated clinical evidence demonstrates that the Prosigna test is more prognostically accurate than other genomic assays, particularly in the critical five- to 10-year breast cancer recurrence window.^2,3

“The PAM50 signature was designed to unlock the clinical utility of modern biological insights into the nature of breast cancer. Through the Prosigna test, these biological insights are now directly informing treatment decisions for patients,” noted Matthew Ellis, M.D., Ph.D., a developer of the PAM50-based Prosigna test. “The OPTIMA results reinforce the need to ground critical decisions upon tumor biology because understanding risk of recurrence and chemotherapy benefit as distinct principles produces safer and more personalized care.”

Veracyte is committed to making the Prosigna test accessible to all eligible breast cancer patients. The test is currently covered by most commercial payers, and patients may qualify for financial assistance or a tailored payment plan supported by the Veracyte Access Program for eligible uninsured and underinsured patients.

Veracyte is a global diagnostics company aiming to transform cancer care for patients globally. The company’s molecular tests assess the biology of each patient’s tumor to help clinicians answer essential questions about cancer care. Veracyte’s Diagnostics Platform combines broad genomic and clinical data, advanced bioinformatics and artificial intelligence (AI), and an evidence-generation engine to support continued innovation and pipeline development. The company’s portfolio includes the Afirma Genomic Sequencing Classifier test, Decipher Bladder Genomic Classifier test, Decipher Prostate Genomic Classifier test, Prosigna Breast Risk of Recurrence test, and the TrueMRD Monitoring Test for MIBC.

References
¹ National Breast Cancer Foundation, Inc., Breast Cancer Facts & Stats; Last updated Apr 20, 2026. https://www.nationalbreastcancer.org/breast-cancer-facts/#mortality.
² Dowsett M, et al. J Clin Oncol. 2013;31(22):2783-2790.
³ Sestak et. al., JNCI (2013);105(19).