Press Announcements > FDA announces approval, CMS proposes coverage of first breakthrough-designated test to detect extensive number of cancer biomarkers

Press Announcements > FDA announces approval, CMS proposes coverage of first breakthrough-designated test to detect extensive number of cancer biomarkers



FDA announces approval, CMS proposes coverage of first breakthrough-designated test to detect extensive number of cancer biomarkers



The U.S. Food and Drug Administration today approved the FoundationOne CDx (F1CDx), the first breakthrough-designated, next generation sequencing (NGS)-based in vitro diagnostic (IVD) test that can detect genetic mutations in 324 genes and two genomic signatures in any solid tumor type. The Centers for Medicare & Medicaid Services (CMS) at the same time proposed coverage of the F1CDx. The test is the second IVD to be approved and covered after overlapping review by the FDA and CMS under the Parallel Review Program, which facilitates earlier access to innovative medical technologies for Medicare beneficiaries. Continue reading.