Genomic Test Guides Chemotherapy Decisions in Early-Stage Breast Cancer

Clinical features alone can leave uncertainty about who may benefit from chemotherapy versus endocrine therapy alone. A newly launched test addresses this challenge by estimating 10-year recurrence risk and predicting chemotherapy benefit to support individualized treatment decisions.

Veracyte (South San Francisco, CA, USA) has introduced the Prosigna Breast Risk of Recurrence (ROR) test in the United States, with ordering available beginning June 8, 2026. The genomic assay uses whole-transcriptome next-generation sequencing and is intended for patients with early-stage hormone receptor–positive (HR+) breast cancer. The launch follows presentation of the OPTIMA trial readout at the American Society of Clinical Oncology (ASCO) Annual Meeting.

The test determines an ROR score and estimates the 10-year probability of distant recurrence by integrating biological, clinical, and pathological information into a single analysis. Built on the PAM50 genomic classifier, it assigns tumors to one of four intrinsic subtypes and incorporates a proliferation score alongside clinical factors. These outputs are designed to inform treatment planning, including whether high-risk patients are likely to benefit from chemotherapy or may achieve optimal outcomes with endocrine therapy alone.

New data from the OPTIMA trial indicate that nodal involvement and other clinical risk factors do not automatically correspond to high recurrence risk; more than two-thirds of node-positive patients who previously might have received chemotherapy could avoid it based on Prosigna results. The test has been shown to be predictive for chemotherapy benefit decisions in a phase III prospective trial across premenopausal and postmenopausal women with high-risk disease, including those with up to nine positive nodes. Cited clinical evidence also highlights prognostic accuracy in the 5–10-year recurrence window.

In the U.S., more than 225,000 cases of HR+/human epidermal growth factor receptor 2-negative (HER2-) breast cancer are diagnosed annually, and five-year survival can reach 92% when detected early and treated appropriately. Veracyte reports the test is covered by most commercial payers, with financial assistance options available through the Veracyte Access Program. Ordering is offered nationwide via the company’s online portal beginning June 8, 2026.

"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,” said Matthew Ellis, M.D., Ph.D., one of the developers of the PAM50-based Prosigna test. “The OPTIMA results reinforces 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.”

“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. 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," said Jean Sachs, MSS, MLSP, Chief Executive Officer of Living Beyond Breast Cancer.

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