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.
Read More »Home >> Tag Archives: 23andMe
FDA clears first DTC genetic test on cancer risk
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. ...
Read More »