Veracyte launched its Prosigna Breast Risk of Recurrence assay as a laboratory-developed test (LDT) in the U.S., citing Phase 3 OPTIMA trial evidence that supports safely guiding adjuvant therapy decisions in ER-positive, HER2-negative early breast cancer. The company said the assay’s 50-gene PAM50 signature can support treatment de-escalation by identifying patients with low recurrence scores who may avoid chemotherapy when paired with standard hormonal management. Veracyte also referenced ASCO-shared data that may inform other clinical utility use cases. Veracyte’s commercial framing linked the OPTIMA readout to reimbursement, adoption, and guideline considerations—particularly in higher-risk populations where treatment selection is often based on clinical factors alone. The move further expands the point-of-care footprint of gene expression tests in breast cancer, with direct implications for pathology-to-treatment workflows.