The Food and Drug Administration (FDA) has approved the first clinical test that uses DNA to assess potential risk of opioid use disorder in certain patients, according to an FDA announcement. The new AvertD test is intended as a screening tool clinicians can use before prescribing oral opioid drugs in adult patients who are being considered for short-term treatment of acute pain and who have not previously used oral opioid pain medications. To administer at the point of care, the clinician would swab the cheek of a patient to collect a DNA sample. The lab test then assesses a combination of genetic variants that could signify an elevated risk of developing opioid use disorder. According to the FDA, AutoGenomic, Inc., the maker of the test, will be on task to provide training to prescribers and to conduct a large post-market study to evaluate the product’s real-world performance over time. AvertD is not intended for patients with chronic pain, the FDA said.
Part of the big picture: “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,” FDA said. Federal estimates say about 2 million Americans have opioid use disorder, and many more are at risk. The test’s best general use might be to inform patients of their baseline risk—a piece of information that could be important prior to scheduling procedures and in relation to acute injuries.