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Test to Assess OUD Risk in Acute Pain Patients Receives FDA Approval
A test that uses DNA to assess whether certain individuals are at a heightened risk of developing opioid use disorder (OUD) was recently approved by the Food and Drug Administration (FDA).
Developed by AutoGenomics, Inc., the AvertD test is intended to be administered prior to first exposure to oral opioid pain medications in patients, such as those scheduled for a surgical procedure, who are being considered for a prescription of 4 to 30 days to treat acute pain. (The test is not intended for use with chronic pain patients.)
A previous version of the AvertD test was rejected by an FDA advisory committee panel in October 2022. After receiving recommendations from the panel, AutoGenomics collaborated with the FDA to develop the modified version of the test that received approval from the administration on December 19, 2023.
Available by prescription only, the AvertD test is for patients at least 18 years of age who consent to the test and have no prior use of oral opioid analgesics. The test is administered by a healthcare provider, who swabs the patient’s cheek to collect a DNA sample. The sample is then analyzed for a combination of genetic variants 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,” Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a news release. “AvertD may help patients who are concerned about being treated with an opioid for acute pain make better informed decisions.”
Per terms of the FDA’s approval, AutoGenomics must provide training to healthcare providers on appropriate use of the test and also conduct a post-market study to assess its performance, with regular study progress reports delivered to the FDA.
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