Experts Ask FDA to Revoke Approval for Test to Predict Genetic Risk of Opioid Use Disorder

A group of doctors and researchers is asking the Food and Drug Administration (FDA) to revoke its approval of a test designed to predict the genetic risk of developing opioid use disorder, NBC News reports.

The FDA approved the test, called AvertD in December. It detects 15 genetic markers that the manufacturer claims are linked to OUD. It is designed to be used before a person is prescribed an opioid for the first time, such as before surgery.

In a letter to FDA Commissioner Robert Califf, the experts said AvertD does not predict opioid use disorder (OUD) “any better than chance.” The letter stated, “This test is based on an approach that has been abandoned by mainstream genetics.”

The group said that “the harmful consequences of an invalid genetic test for OUD are clear. Patients who test negative, and their clinicians, may have a false sense of security about use of opioids.”

The FDA’s own independent advisory committee overwhelmingly voted against Avert D’s approval in 2022 because of concerns that it may not identify people at risk for opioid use disorder, potentially leading to overprescribing.