FDA approves first genetic test to help identify risk for OUD

Abstract

On Dec. 19, 2023, the U.S. Food and Drug Administration approved the first test that uses DNA in assessing whether certain individuals may have an elevated risk of developing opioid use disorder (OUD). As part of a clinical evaluation, the AutoGenomics, Inc. AvertD test is intended to be used prior to first exposure to oral opioid pain medications in patients being considered for a 4–30‐day prescription for the treatment of acute pain, such as in patients scheduled to undergo a planned surgical procedure. “The AvertD test, a prescription‐use only genetic laboratory test for patients 18 years and older, is to be used only with patients who consent to the test and have no prior use of oral opioid analgesics,” said Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health. “The test is administered by a health care provider by swabbing the cheek of a patient to collect a DNA sample that will be used to determine if a patient has a combination of genetic variants that may be associated with an elevated risk of developing OUD. This information should be used as part of a complete clinical evaluation and risk assessment; it should not be used alone to make treatment decisions. The test is not intended to be used in patients being treated for chronic pain. AvertD may help patients who are concerned about being treated with an opioid for acute pain make better informed decisions.” As part of the approval order, AutoGenomic, Inc. must provide training to health care providers to help ensure appropriate use of the test and conduct a large post‐market study assessing device performance in patients, regularly reporting progress made toward completion of that study to the FDA. The primary risks associated with AvertD are false negative and false positive results.