In clinical trials, the test accurately assessed a raised risk for addiction 83 percent of the time
The U.S. Food and Drug Administration has approved a first-of-its-kind test — the AvertD test — that uses DNA swabbed from a patient’s cheek to determine if they have a combination of genetic variants associated with an elevated risk for opioid addiction.
The 15 genetic variants detected by the test are involved in the brain reward pathways that are associated with opioid use disorder, the FDA explained.
The AvertD test, manufactured by AutoGenomics Inc., is meant to help doctors assess the risk of prescribing opioid painkillers to patients about to undergo surgery, the FDA said. The test is prescription-only and is to be used with a patient’s consent if they have no prior use of opioids. The FDA noted that the test is not intended to be used in patients being treated for chronic pain and should not be used as the sole way to assess a person’s risk for opioid addiction.
The approval is based on a clinical trial involving 385 people, according to materials from an October 2022 advisory committee meeting evaluating the test’s merits. Of those participants, 175 had a diagnosed opioid use disorder. The AvertD test accurately detected those at risk for opioid addiction about 83 percent of the time, results showed. It accurately ruled out those not at risk about 80 percent of the time. However, test accuracy varied between ethnicities. The AvertD test accurately detected risk for opioid addiction about 81 percent of the time in Whites but nearly 92 percent of the time in Hispanics.
The FDA also noted there are risks associated with the AvertD test, mainly false-negative and false-positive results. A false positive could lead to a person being denied opioid painkillers even though they have no elevated genetic risk for addiction, the FDA said. Meanwhile, a false negative could lead to someone becoming addicted because the test indicated they were not at increased risk for opioid use disorder.
As part of the approval, AutoGenomic must provide training to health care professionals to ensure appropriate use of the test, the FDA said.
