Veracyte launched its Prosigna Breast Risk of Recurrence assay as a laboratory-developed test (LDT) in the U.S. after clinical trial data presented at ASCO supported its use in guiding adjuvant therapy decisions for patients with ER-positive, HER2-negative early-stage breast cancer. The OPTIMA trial evaluated whether treatment guidance based on Prosigna could safely avoid chemotherapy in certain low-risk patients. Veracyte said the Phase 3 randomized OPTIMA readout validates Prosigna in a broad high-risk population and highlighted reimbursement and adoption as the next gating steps for clinical integration. Prosigna uses the PAM50 gene signature to compute a risk of recurrence score used to steer therapy choices. The company also pointed to additional evidence around its Decipher Prostate Metastatic Classifier to identify patients more or less likely to benefit from docetaxel addition. The central industry implication is continued movement toward gene-expression classifiers that can reduce overtreatment while maintaining outcomes.