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BioWorld - Friday, May 1, 2026
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Home » FDA advisory panel says no to test for opioid use disorder
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FDA advisory panel says no to test for opioid use disorder

Oct. 27, 2022
By Mark McCarty
A U.S. FDA advisory panel saw a number of problems in the clinical trial for the Avertd test for opioid use disorder (OUD), including the fact that the study failed to enroll a sufficiently ethnically diverse body of subjects. Perhaps more damning was that the advisory panel was uncertain as to whether the 15 single nucleotide polymorphisms (SNPs) evaluated in the test were helpful in sorting out which patients were truly at high risk of OUD, leading to an 11-2 vote that the probable benefits of the test do not outweigh the risks.
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