FDA Approves First Test to Identify Elevated Risk of Developing Opioid Use Disorder
The FDA 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. The test is not intended to be used in patients being treated for chronic pain. The AvertD test is a prescription-use only genetic laboratory test to be used only with patients who consent to the test and have no prior use of oral opioid analgesics. 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.
