FDA Approves First Test to Help Identify Elevated Risk of Developing Opioid Use Disorder

December 26, 2023

On Tuesday, December 19, 2023, the United States Food and Drug Administration (FDA) approved the first test that uses DNA to assess whether certain individuals may have an elevated risk of developing opioid use disorder (OUD), the AvertD test from AutoGenomics, Inc.

The test is intended to be used prior to first exposure to oral opioid pain medications in patients being considered for prescriptions for the treatment of acute pain. The test is a prescription-use only genetic laboratory test for patients who are 18 years and older, and is to be used only with patients who consent to the test and who have no prior use of oral opioid analgesics.

As shared in an FDA news release, attributed to Jeff Shuren, MD, JD, Director of the FDA's Center for Devices and Radiological Health, "The opioid crisis, one of the most profound public health issues facing the United States, calls for innovative measures to prevent, diagnose and treat opioid use disorder, including to assess the risk of developing the disorder . . . This approval represents another step forward in the FDA's efforts to prevent new cases of OUD, support the treatment of those with the disorder and decrease the misuse of opioid analgesics."

Click here to access the FDA news release announcing the approval and for more information.

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