Veracyte launched its Prosigna breast risk of recurrence assay in the U.S. after investors received trial data presented at ASCO demonstrating that the test can guide adjuvant therapy decisions for ER-positive, HER2-negative patients with high-risk features. The company emphasized evidence from the Phase 3 OPTIMA trial as a reimbursement and guideline-adoption catalyst. Prosigna evaluates 50 genes (PAM50) to generate a recurrence score intended to identify patients who may safely avoid chemotherapy while receiving appropriate endocrine therapy. Veracyte also pointed to additional ASCO data supporting its prostate metastatic classifier use case. The move places Prosigna into a more directly monetizable pathway, where payers and practice guidelines can translate trial-backed utility into routine ordering. For oncology diagnostics providers, the key takeaway is that ASCO-stage evidence increasingly drives the timing of market entry and the credibility needed to expand reimbursement.
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