Press Announcements > FDA authorizes first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism

Press Announcements > FDA authorizes first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism



FDA authorizes first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism

Today, the U.S. Food and Drug Administration permitted marketing, with special controls, of the 23andme Personal Genome Service Pharmacogenetic Reports test as a direct-to-consumer test for providing information about genetic variants that may be associated with a patient’s ability to metabolize some medications to help inform discussions with a health care provider. The FDA is authorizing the test to detect 33 variants for multiple genes