Medical Doctors, Geneticists and Other Experts Call on CMS to Deny Coverage, and FDA to Rescind Approval of Invalid Genetic Test for Opioid Addiction
Test Approved by FDA, Based on Science that Has Largely Been Abandoned by Main Stream Genetics, Does not Predict Addiction Risk and Could Lead to Opioid Overprescribing
WASHINGTON, D.C. – A recently approved genetic test that claims to predict risk of opioid addiction is based on old genetic studies that have largely been abandoned. A broad coalition of geneticists and doctors, other experts said in a letter sent to the U.S. Food and Drug Administration (FDA) urging the agency to retract approval and a letter to the Centers for Medicare and Medicaid Services (CMS) requesting denial of coverage. The test, called AvertD, was approved despite opposition from the FDA’s expert advisory committee, which voted 11-2 against approval. FDA surprised observers by approving the test despite this widespread opposition.
The test identifies 15 genetic markers. However, an independent scientific review of these markers states that AvertD does not predict risk of opioid addiction better than chance. Notably, false-negative results from AvertD may encourage harmful use of opioids and false positive results could wrongly brand patients as prone to addiction.
Read the letters to FDA and CMS here:
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