Researchers, Physicians Urge FDA to Revoke Approval of Genetic Tests for OUD

A genetic risk assessment for opioid addiction approved by the FDA “may make the opioid crisis worse,” according to 31 physicians, researchers and scientists who ripped the agency and the test in a scathing letter Thursday to Commissioner Robert Califf, requesting the approval be revoked.

AvertD — developed to screen for genetic markers and identify if an adult has a higher likelihood of developing opioid use disorder (OUD) — received a thumbs down from an FDA advisory panel 18 months ago. The panel cited multiple concerns that could result from opioids being prescribed, or not prescribed, based on faulty test results.

With the addition of provider training and postmarket studies required of the manufacturer, California-based SOLVD Health, the FDA approved AvertD last December while again recognizing the risks involved with false negative and false positive test results, an issue repeated and emphasized in the letter.

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