The U.S. Food and Drug Administration (FDA) provided 23andMe (Mountain View, Calif.) authorization for the first direct-to-consumer (DTC) test for detecting genetic variants that may be associated with medication metabolism. However, the very next day, the FDA released a safety communication warning consumers and physicians against making treatment decisions based on genetic tests that claim to predict patients’ responses to specific medications. While the 23andMe authorization included similar cautions in the special controls, the safety communication went further cautioning against claims of tests developed as laboratory-developed tests. Unlike 23andME, other companies that offer PGx tests as a laboratory-developed test—Genomind, Assurex, and Color—require the test to be ordered through a medical provider. “Tests that make such claims [how a patient will respond to specific medications] that have not been evaluated by the FDA and are not supported by prescribing recommendations in the FDA-approved drug label, may not be supported by scientific and clinical evidence, and may not be accurate,” the agency wrote. The agency said it is concerned about health care providers and patients inappropriately selecting or changing drug treatment based on the results from “insufficiently substantiated genetic tests.” Specifically, the FDA calls out PGx tests marketed to improve antidepressant prescribing. […]