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Veracyte launches Prosigna breast cancer test in US market

June 1, 2026 7:30 AM

Veracyte Inc. (NASDAQ: VCYT) announced the U.S. commercial launch of its Prosigna Breast Risk of Recurrence test for patients with early-stage hormone-receptor positive breast cancer. The genomic test will be available for ordering starting June 8, 2026.



The Prosigna test determines a patient's risk of recurrence score and estimates the 10-year probability of distant recurrence in breast cancer patients. The test combines intrinsic subtypes and proliferation score with clinical factors to assess whether patients may benefit from chemotherapy or can safely receive endocrine therapy alone.



The announcement follows results from the OPTIMA trial presented at the ASCO Annual Meeting, which showed that more than two-thirds of node-positive patients who previously might have received chemotherapy can avoid it based on Prosigna test results, according to the company.



In the United States, more than 225,000 new hormone-receptor positive, HER2-negative breast cancer cases are diagnosed annually. The test is designed for patients with early-stage breast cancer where five-year survival rates reach 92% when diagnosed early and treated appropriately.



The Prosigna test was developed from the PAM50 genomic classifier and classifies individual tumors into one of four intrinsic subtypes. Veracyte states the test is covered by most commercial payers and that patients may qualify for financial assistance through the company's access program.



The test will be available through Veracyte's nationwide network via the company's ordering portal. Veracyte is a cancer diagnostics company that offers molecular tests for thyroid, prostate, bladder and breast cancers.

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