FDA Approves Consumer Pharmacogenetics Test

In October, the Food and Drug Administration (FDA) announced that the agency had authorized 23andMe to begin marketing the first direct-to-consumer pharmacogenetics test. The 23andMe Personal Genome Service Pharmacogenetic Reports test assesses a person’s DNA for 33 genetic variants that have been linked with faster or slower than average drug metabolism.

For this category of device, the FDA established six special controls, intended to assure the test’s safety and effectiveness. Among the controls is a requirement that the label warns individuals against using the test results to stop or change any medication.

“This test should be used appropriately because it does not determine whether a medication is appropriate for a patient, does not provide medical advice, and does not diagnose any health conditions,” said Tim Stenzel, M.D., Ph.D., director of the FDA’s Office of In Vitro Diagnostics and Radiological Health in a press release. “Any medical decisions should be made only after discussing the results with a licensed health care provider and results have been confirmed using clinical pharmacogenetic testing.” ■