U.S. Food & Drug Administration Clears First Direct-To-Consumer Pharmacogenetic Test From 23andMe

The U.S. Food and Drug Administration (FDA) recently cleared DNA-testing company 23andMe to begin marketing the first ever direct-to-consumer pharmacogenetic test. Pharmacogenetic tests evaluate an individual’s potential response to a particular drug therapy, and are sometimes used to help predict the development of genetic diseases.

With the clearance, 23andMe will now be able to advertise its Personal Genome Service Pharmacogenetic Reports to consumers, which identify 33 different variants among eight genes in order to try and predict a person’s ability to metabolize medications. Specifically, 23andMe may now use this information to tell consumers whether . . .