The Food and Drug Administration is facing backlash over its approval of a genetic test intended to determine if a person is at increased risk for opioid addiction.
The test, called AvertD, was approved by the FDA in December. It detects a handful of genetic markers that the manufacturer, California-based SOLVD Health, claims are associated with opioid use disorder. It’s meant to be used before a person is prescribed an opioid for the first time; for example, ahead of a surgery that a doctor may prescribe a short course of opioids for recovery.
It’s a promising test, in theory: An opioid prescription, even short-term, can be a path to addiction for some people.
The opioid crisis in the United States has been responsible for almost 645,000 deaths over the last two decades. In 2022, about 6.1 million people in the U.S. were reported to have an opioid use disorder, according to the Substance Abuse and Mental Health Services Administration.
The agency’s clearance of AvertD, however, went against the advice of its own independent advisory committee, which overwhelmingly voted against approval in 2022 because of concerns that the test may fail to identify people at risk for opioid use disorder, potentially leading to overprescribing.
In a letter addressed to FDA Commissioner Robert Califf dated Thursday, a group of doctors and researchers called on the agency to revoke its approval, saying the test doesn’t predict opioid use disorder “any better than chance.”
