The First Direct-To-Consumer BRCA Cancer Gene Test Comes With Caveats

On Tuesday March 6, the Food and Drug Administration approved the first direct-to-consumer test that reports on BRCA1- and BRCA 2-related genetic risk for breast, ovarian, and prostate cancer.

The approval comes on the heels of a change in the FDA’s regulatory requirements last November, which paved the way for companies to market new genetic health risk tests. Until this test, patients had to go to doctors or genetic counselors to get information about their genetic cancer risk. With the newly-approved BRCA test, however, people can send their saliva samples directly to 23andMe.


Read at: Genome Magazine