23andMe Authorized by FDA to Market First Direct-to-Consumer Genetic Test
February 20, 2015
(Medical Xpress) – 23andMe today announced that it has been granted authority by the U.S. Food and Drug Administration (FDA) to market the first direct-to-consumer genetic test under a regulatory classification for novel devices. 23andMe’s Personal Genome Service 510(k) submission for Bloom Syndrome Carrier Status test report was evaluated through the de novo regulatory pathway. 23andMe submitted an application for review under the standard 510(k) requirements.