FDA Approves FoundationOne CDx, CMS Agrees to Cover

November 30, 2017 – The FDA has approved the FoundationOne CDx (F1CDx) cancer biomarker assay concurrently with a decision from the Centers for Medicare & Medicaid Services (CMS) to provide insurance coverage for the next-generation sequencing (NGS)-based in vitro diagnostic (IVD) test. F1CDx, which detects 324 different genes, is a “more extensive” assay that can identify actionable mutations across 5 tumor types for 15 different targeted therapies … (leggi tutto)