Veracyte launched its Prosigna Breast Risk of Recurrence assay as a laboratory-developed test (LDT) in the US after ASCO 2026 presentations tied to the Phase 3 OPTIMA trial. Company executives said the new evidence package is intended to support reimbursement, clinical adoption, and guideline inclusion. In OPTIMA, investigators tested whether treatment guided by the Prosigna PAM50-based risk score could safely reduce chemotherapy use in selected ER-positive, HER2-negative patients. The company positioned the results as validation across a broad high-risk population, including patients with more extensive nodal involvement. Veracyte also highlighted additional ASCO data for its Decipher Prostate Metastatic Classifier, describing how the classifier may help distinguish who might benefit from adding docetaxel to androgen deprivation therapy. For the diagnostics market, the LDT launch indicates a commercialization push to bring gene-expression risk scores into routine decision pathways while supporting payor and clinician confidence through large randomized evidence.