23andMe’s Pharmacogenetic Test Approved by FDA

The FDA has just approved 23andMe’s Personal Genomic Service (PGS) Pharmacogenetic Reports. This marks the first direct-to-consumer test for pharmacogenetics of enzyme variants that may affect the way patients break down medications. Consumers collect their saliva into 23andMe’s testing kit, mail it to the company’s labs, and then receive the results via an online portal. The approved pharmacogenetic assessment system looks for 33 variants of common enzymes that affect medication metabolism, including CYP2C19, CYP2C9, CYP3A5, UGT1A1, DPYD, TPMT, SLCO1B1, and CYP2D6. The full list of variants can be found here.
“This test is a step forward in making information about genetic variants available directly to consumers and better inform their discussions with their health care providers. We know that consumers are increasingly interested in genetic information to help make decisions about their health care,” said Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, in a press release.