The FDA has allowed 23andMe to market a new direct-to-consumer genetic test that provides information about how a person metabolizes some medications. The test, approved to detect 33 variants of multiple genes, has been cleared with special controls to ensure “reasonable assurance of safety and effectiveness.”
The Personal Genome Service Pharmacogenetic Reports test analyzes DNA from a saliva sample collected by the individual. The report then describes whether that person has variants in certain genes that may be associated with their ability to metabolize, and therefore respond to, some drugs. Consumers can bring this information to their discussions with a healthcare provider.
What the test doesn’t do is provide information on a person’s ability to respond to any specific drug, the FDA said in a statement Wednesday.
“This test is a step forward in making information about genetic variants available directly to consumers and better inform their discussions with their healthcare providers,” 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 the statement. “We know that consumers are increasingly interested in genetic information to help make decisions about their healthcare.”
“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. Consumers should not use this test to make treatment decisions on their own,” he said.
Healthcare providers shouldn’t use the test to make treatment decisions either, the FDA said. They should confirm the results using clinical pharmacogenetic testing before making any medical decisions.
The FDA approved the test via its de novo pathway, establishing six special controls. These include a labeling requirement that a warning statement must be included noting that the consumer should not use the test results to stop or change any medication.