FDA-Approved Test Provides Pharmacogenetic Reports Directly to Consumers

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23andMe provides the reports directly to customers, without a prescription.
23andMe provides the reports directly to customers, without a prescription.

The Food and Drug Administration (FDA) has approved the first direct-to-consumer test to detect genetic variants that may be associated with a patient's ability to metabolize certain medications.

The 23andMe Personal Genome Service Pharmacogenetic Reports test can detect 33 variants for multiple genes, corresponding to more than 50 commonly prescribed medications and over-the-counter products. After providing a self-collected saliva sample, a pharmacogenetic report is generated which describes how the patient's genetics may impact the way certain drugs are metabolized. The test does not provide details on pharmacogenetic response to a specific drug, but rather whether the patient is predicted to be a fast or slow metabolizer. In addition, it should not be used to make treatment decisions; healthcare providers should confirm the results with independent pharmacogenetic testing.

The FDA's authorization for marketing was based on data reviewed through the de novo premarket review pathway. In addition, the Agency is establishing multiple special controls, or criteria, to provide "reasonable assurance of safety and effectiveness for this test." One of these includes a labeling requirement stating that consumers should not use the test results to stop or change their medication. 

"We know that consumers are increasingly interested in genetic information to help make decisions about their health care,” said Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health. “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."

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For more information visit FDA.gov.

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