News Report | November 26, 2018
FDA Authorizes 23andMe Direct-To-Consumer Pharmacogenetic Reports
On October 31, 2018, the U.S. Food and Drug Administration (FDA) authorized direct-to-consumer marketing of the 23andMe Personal Genome Service Pharmacogenetic Reports test. The FDA authorized the test, which detects 33 variants for multiple genes linked to the ability to metabolize medications. Pharmacogenetics is the process of understanding what, if any, role genetics plays in an individual's reaction to medications. Consumers can use the test results to inform discussions about treatment with their health care professionals.
For the approval, the FDA reviewed information submitted by 23andMe to demonstrate that the test can correctly identify genetic variants . . .