FDA, CMS Approve Foundation Medicine's Solid Tumor Test with Proposed Coverage

Foundation Medicine has gained FDA approval and a concurrent coverage proposal from the Centers for Medicare & Medicaid Services (CMS) for its FoundationOne CDx™ cancer test, a companion diagnostic designed to detect genetic mutations in 324 genes and two genomic signatures in any solid tumor type.FoundationOne CDx is a next-generation sequencing (NGS)-based in vitro diagnostic (IVD) device created to detect substitutions, insertion and deletion alterations (indels), and copy number al