FDA approves Foundation Medicine's cancer Dx, CMS proposes coverage

Under the FDA/CMS Parallel Review Program, an in vitro diagnostic (IVD) test for cancer from Foundation Medicine Inc. (NASDAQ:FMI) gained FDA approval as well as proposed coverage by CMS.

The laboratory-developed test (LDT), FoundationOne CDx, detects genetic mutations in 324 genes and two genomic signatures in any solid tumor type. FDA said it identifies all somatically altered genes that are validated targets for therapy or drivers of oncogenesis. The agency added that the test can also be used as a companion diagnostic to identify which patients may benefit from 15 different FDA-approved targeted treatment options for non-small cell lung cancer (NSCLC), melanoma, breast cancer, colorectal cancer or ovarian cancer...