Despite 23andMe Authorization, FDA Cautious About PGx Testing

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.

Citing warfarin sensitivity as an example, the agency said only FDA-approved labeling for a drug and/or companion genetic test provide health care providers with adequate information on how to use genetic information reported by the genetic test to manage medication treatment using the drug. The FDA further warned that is is looking into certain developers that may be “inappropriately selling genetic tests for the unapproved uses” and will take compliance actions, if necessary.

23andMe’s Authorization
The FDA expanded the approved marketing of the 23andMe Personal Genome Service Pharmacogenetic Reports test to include information about 33 genetic variants in eight genes linked with a metabolism of drugs, including 50 commonly prescribed and over the counter medications (CYP2C19, CYP2C9, CYP3A5, UGT1A1, DPYD, TPMT, SLCO1B1, and CYP2D6).

The FDA reviewed data for the test through the de novo premarket review pathway. With the authorization, the FDA is established six special controls, including a labeling requirement with a warning statement noting that the consumer should not use the test results to stop or change any medication. The FDA’s review determined the test is accurate (can correctly identify the genetic variants in saliva samples) and that it can provide reproducible results. Additionally, the company submitted consumers understood test instructions and reports.

However, the FDA says the authorization is not intended to provide information on a patient’s ability to respond to any specific medication and warns that health care providers should not use the test to make any treatment decisions, without additional clinical testing.

“The authorization allows us to provide customers with information on whether they are predicted to be fast or slow metabolizers based on their genetics, and when supported by appropriate clinical evidence, whether they may experience reduced efficacy or have an increased chance of side effects from certain medications,” the company wrote on its blog. 

“We’ve continued to innovate through the FDA and pioneer safe, effective pathways for consumers to directly access genetic health information,” said 23andMe cofounder and CEO Anne Wojcicki. “Pharmacogenetic reports are an important category of information for consumers to get access to and I believe this authorization opens the door for consumers to work with their health providers to better manage their medications.”

With this authorization, the company has now received FDA authorization or clearance for all categories of its original products.

“This test is a step forward in making information about genetic variants available directly to consumers and better inform their discussions with their health care providers,” said Tim Stenzel, director of the FDA’s Office of In Vitro Diagnostics 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.”

Takeaway: Despite the new authorization of 23andMe’s Personal Genome Service Pharmacogenetic Reports to include PGx information, the FDA is taking a cautious stance on laboratory-developed PGx tests.


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