Tag Archives: 23andMe

December 2018—The FDA has granted 23andMe de novo authorization to offer direct-to-consumer reports on pharmacogenetics. The authorization allows 23andMe to report variants in multiple genes that are associated with how an individual may metabolize some medications.

March 16, 2018—23andMe received the first FDA authorization for a direct-to-consumer genetic test for cancer risk. The authorization allows 23andMe to provide customers, without a prescription, information on three specific BRCA1/BRCA2 breast cancer gene mutations that are most common in people of Ashkenazi Jewish descent. These three mutations, however, are not the most common BRCA1/BRCA2 mutations in the general population. ...