FDA Approves First Genetic Test for Medication Metabolism

The FDA has approved the first direct-to-consumer test to assess patients' ability to metabolize medication.

The test, created by the genetics testing company 23andMe, is approved to detect 33 variants for multiple genes.

The test uses a self-collected saliva sample and reports the presence of certain variants that are associated with the ability to metabolize certain medications.

“The test does not describe an association between the detected variants and any specific drug nor whether a person will or will not respond to a particular drug. Furthermore, health care providers should not use the test to make any treatment decisions. Results from this test should be confirmed with independent pharmacogenetic testing before making any medical decisions,” the FDA warned.

—Michael Potts

Reference:

FDA authorizes first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism [press release]. FDA. October 31, 2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm624753.htm.