Testimony Before the FDA’s Clinical Chemistry and Clinical Toxicology Devices Panel Opposing Marketing Authorization of the AvertD Genetic Test to Predict the Risk of Opioid Use Disorder
In testimony before the Food and Drug Administration’s (FDA’s) Clinical Chemistry and Clinical Toxicology Devices Panel, which was convened to consider the AvertD genetic test for predicting opioid use disorder risk in patients prior to their first prescription of an opioid, Public Citizen argued against marketing authorization because there was insufficient evidence of the device’s effectiveness and other research indicated such genetic-based predictions are scientifically implausible.