Posted by Michael Wonder on 01 Dec 2017
FDA announces approval, CMS proposes coverage of first breakthrough-designated test to detect extensive number of cancer biomarkers
30 November 2017 - Agencies’ parallel review process makes test for efficient identification of multiple targeted therapy options available to health care professionals, patients and eligible Medicare beneficiaries sooner.
The U.S. FDA today approved the FoundationOne CDx (F1CDx), the first breakthrough-designated, next generation sequencing-based in vitro diagnostic (IVD) test that can detect genetic mutations in 324 genes and two genomic signatures in any solid tumour 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.
