Veracyte launched Prosigna Breast Risk of Recurrence as a laboratory-developed test (LDT) in the US after ASCO data suggested the assay can safely guide adjuvant treatment decisions for patients with ER-positive, HER2-negative early breast cancer. Veracyte tied the launch strategy to evidence from the Phase III OPTIMA trial. The OPTIMA study tested whether Prosigna-guided treatment was non-inferior to standard-of-care chemotherapy plus hormone therapy, with invasive breast cancer-free survival as a primary endpoint. Veracyte executives argued the OPTIMA data support broader use of Prosigna across high-risk populations and may support reimbursement and guideline adoption. The launch also referenced additional ASCO-linked evidence for Veracyte’s Decipher Prostate Metastatic Classifier in metastatic prostate cancer decision-making.