Clinicians Slam FDA Over Approval of Opioid Addiction Test

A group of researchers is urging US regulators to revoke the approval of a genetic test called AdvertD for predicting the risk of opioid addiction. The researchers argue that the test may not accurately predict genetic risk for opioid use disorder (OUD), leading to potentially harmful consequences. They believe that the test may give patients and clinicians a false sense of security or result in the unnecessary withholding of opioids. While the FDA approved the test in December, critics are concerned about its sensitivity and specificity in accurately predicting OUD risk. The debate highlights the complex nature of addiction risk factors beyond genetics.

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