Veracyte launched its Prosigna Breast Risk of Recurrence assay as a laboratory-developed test in the US after presenting clinical trial data supporting its use to guide adjuvant therapy decisions in ER-positive, HER2-negative breast cancer. Veracyte said evidence from the phase 3 OPTIMA trial supports safely using Prosigna to determine whether chemotherapy can be avoided for certain patients. The OPTIMA design evaluated whether treatment guided by Prosigna was non-inferior to standard-of-care chemotherapy followed by hormone therapy, with invasive breast cancer-free survival as the primary endpoint. Veracyte is also pointing to additional ASCO data for its Decipher prostate metastatic classifier, which it said helped distinguish patients likely to benefit from adding docetaxel. The launch is geared toward reimbursement, adoption, and potential guideline inclusion—critical hurdles for companion and risk-stratification assays in oncology care pathways.