Buoyed by the remarkable results of the OPTIMA trial presented at the ASCO Annual Meeting, Veracyte this week announced the U.S. 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.
“Prosigna is the only test proven to be predictive for chemotherapy benefit in a Phase III prospective trial for patients with up to nine positive lymph nodes, including premenopausal women, all of whom were recommended to receive ovarian suppression,” Phillip G. Febbo, MD, chief scientific and medical officer at Veracyte, told Inside Precision Medicine.
The Prosigna test determines a patient’s ROR score and estimates the 10-year probability of distant recurrence. It thus 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, helping clinicians to make personalized care plans for their patients.
Prosigna 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%.
“For decades, clinical staging just comprised tumor size and nodal status together with pathology. This was the standard approach to determining whether patients with HR+/HER2- breast cancer need chemotherapy. Many node-positive patients routinely receive chemotherapy as standard of care,” Febbo said.
He added, “And yet, chemotherapy is likely to only benefit a relatively small fraction of these patients.”
The OPTIMA trial uses the Prosigna test to guide therapy and testing. Those patients with a low Prosigna ROR (<60) can safely avoid chemotherapy. OPTIMA shows that tumor biology, as evaluated by the Prosigna test, provides information beyond traditional clinical factors.
Prosigna is based on the PAM50 genomic classifier, which classifies tumors into four intrinsic subtypes. Prosigna, the company said in a press release, “uniquely combines intrinsic subtypes and proliferation score with clinical pathological factors into a single comprehensive analysis to calculate a patient’s Risk of Recurrence (ROR) score and predict 10-year probability of distant recurrence.”
Veracyte’s portfolio includes multiple cancer types, including tests for prostate cancer (Decipher Prostate), bladder cancer (Decipher Bladder and TrueMRD for muscle invasive bladder cancer monitoring), and others. The company said, “Prosigna’s intrinsic subtyping data positions us well for future expansion. While ROR scoring is specific to HR+/HER2- disease, the underlying intrinsic subtyping information spans all breast cancer types.”
More than 225,000 new HR+/HER2- breast cancer cases are diagnosed annually, with approximately 75,000 patients having node-positive disease annually. The OPTIMA trial demonstrated that more than two-thirds of clinically high-risk patients (68%) can safely avoid chemotherapy—a significant population previously assumed to require treatment based solely on nodal status.
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