Business
Veracyte Announces Commercial Launch of the Prosigna Breast Test in the U.S.
Veracyte Announces Commercial Launch of the Prosigna Breast Test in the
About this update from Veracyte, Inc.
On the heels of the landmark OPTIMA trial readout presented at the ASCO Annual Meeting, Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, today announced the U.S. commercial launch of the Prosigna® Breast Risk of Recurrence (ROR) test, a genomic test 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 how a patient’s cancer may behave over time. These insights also 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 care plans for their patients. The Prosigna test will be available to order starting June 8, 2026. “Every patient diagnosed with breast cancer deserves answers they can trust about what their cancer means and what comes next,” said John Leite, PhD, chief commercial officer, Veracyte. “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.” In the U.S., more than 225,000 new HR+/HER2- breast cancer cases are diagnosed each year. 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. Introducing the Prosigna Test: Prediction that adds up 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 ma...