FDA approves first direct-to-consumer test for breast cancer risk

Federal regulators approved the first direct-to-consumer test for the BRCA genes, which increase the risk of breast and ovarian cancer, the agency announced on Tuesday.

The test for the BRCA1 and BRCA2 genes, from , uses a saliva sample. But it assesses only three of the more than 1,000 known BRCA1/2 mutations, raising concerns that women who are told they do not have any of those variants will be lulled into believing that, as a result, they do not have an elevated risk for