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# FDA Approves AvertD Opioid Use Test
- URL: https://www.fdaweb.com/fda-approves-avertd-opioid-use-test/
- Published: 2024-01-02T12:00:00.000Z
- Updated: 2026-09-14T14:19:00.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5156050

FDA has approved AutoGenomics’ AvertD, the first test that uses DNA to assess whether certain individuals may have an increased risk of developing opioid use disorder. CDRH director **Jeffrey Shuren** [says](https://www.fda.gov/medical-devices/medical-devices-news-and-events/fda-approves-first-test-help-identify-elevated-risk-developing-opioid-use-disorder?ref=fdaweb.com) the AvertD test is intended to be used before the first exposure to oral opioid pain medications in patients being considered for a 4-30 day prescription to treat acute pain, such as in patients scheduled to undergo a planned surgical procedure.

The prescription-only test is to be used only with patients who consent to it and have no prior use of oral opioid analgesics, Shuren says. “AvertD may help patients who are concerned about being treated with an opioid for acute pain make better informed decisions,” he says.

As part of the FDA approval, AutoGenomic must train healthcare providers to help ensure appropriate use of the test. It also must conduct a large post-market study assessing device performance in patients, regularly reporting to FDA its progress toward completing the study.