The FDA has granted de novo approval to 23andme Inc. for its report on BRCA1 and BRCA2 risk for developing breast, prostate or ovarian cancer. The direct-to-consumer (DTC) saliva test can provide insight on three genetic mutations linked to the cancers, most commonly found in patients of Eastern European, or Ashkenazi Jewish heritage, which account for a relatively small portion of patients. There are more than 1,000 mutations of the BRCA gene, and the test is not intended to diagnose or rule out the presence of mutation, or increased risk of the particular cancers due to other factors.

Foundation Medicine Inc.'s pan-cancer detection test has received a nod from the FDA, making it one of the most comprehensive companion diagnostics to receive approval from the agency. Concurrent with FDA approval, the Centers for Medicare and Medicaid Services issued a preliminary National Coverage Determination (NCD) for the Foundationone Cdx.