FDA Approval Letter For 23andMe Personal Genome Service (PGS) Test

On April 6, 2017, the federal Food and Drug Administration (FDA) released this approval letter for the 23andMe personal genome services test. The letter details the approved uses for the test, and classifies the test as a class II genetic health risk assessment system for 10 diseases and conditions. This is the first direct-to-consumer tests authorized by the FDA that provide information on an individual’s genetic predisposition to certain medical diseases or conditions, which may help to make decisions about lifestyle choices or to inform discussions with a health care professional . . .