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FDA Targets Unapproved Genetic Tests Claiming to Predict Medication Response


The regulator issued a warning to providers and patients just one day after approving a 23andMe direct-to-consumer test regarding medication metabolism.

fda genetic tests,fda warning,genetic testing claims,safety communication

The FDA issued a warning regarding genetic tests that are being marketed with unapproved claims that they can predict patient medication responses.

Just a day after the U.S. Food and Drug Administration (FDA) approved 23andMe’s direct-to-consumer genetic test that examines how someone’s body might react to certain medications, the regulator warned patients and healthcare providers to avoid using assessments that make similar but unapproved claims.

In the safety communication issued yesterday, the FDA said it is investigating companies that sell pharmacogenetic tests, which claim to predict a patient’s response to medications, without FDA approval. Officials plan to “take compliance actions when appropriate,” continuing what has long been a contentious relationship between the regulator and genetic testing companies.

>> READ: 23andMe Secures FDA Approval for First DTC Genetic Test for Medication Metabolism

“We have so much more to learn about the use of these tests for specific medications, what the results mean and how we can apply the information to improve a patient’s health,” FDA directors Jeffrey Shuren, M.D., J.D., and Janet Woodcock, M.D., said in a statement. “While we are committed to supporting innovation in this area, we will also be vigilant in protecting against the potential risks.”

The FDA warned that the results of tests that make unproven claims could steer inappropriate clinical decision making and result in possible “serious health consequences” for patients.

Some genetic tests, regulators noted, claim to help physicians select which antidepressant drug to prescribe, based on the potential for adverse effects or increased effectiveness. But the science is still out on whether and how genetic variants are associated with the efficacy of antidepressant medications.

Throughout the document, the FDA makes clear that the issue stems from a lack of scientific evidence. The problem is not that these genetic tests are incapable of providing valuable insights; it’s that researchers have not yet proved that to be true. In the future, after satisfying the FDA, more genetic tests could hit the market with validated claims regarding the medication response predictions.

“We believe, with more scientific study, there is great potential for pharmacogenetics,” Shuren and Woodcock said.

In addition to 23andMe’s direct-to-consumer pharmacogenetic test, the regulator has authorized genetic tests that inform patients of drug-metabolizing enzymes that signal things like warfarin sensitivity.

But even this week’s approval came with special controls, including a labeling requirement to warn patients not to stop or change their medication use based on tests results alone. The FDA drove home that the 23andMe test does not deliver a medical diagnosis, and physicians should make medical decisions only after they confirm a finding in the clinic.

In short, even approved pharmacogenetic tests aren’t meant to guide treatment decisions. The FDA sees them as conversation starters.

The agency also noted that some software programs are being marketed with similar medication response claims. Officials advised clinicians and patients to avoid those services as well.

“We will continue to monitor reports of adverse events associated with this issue and will keep the public informed if significant new information becomes available,” the FDA wrote in the safety communication.

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