First DNA-Based OUD Risk Test Wins FDA Approval on Second Attempt

After an October 2022 advisory committee rejection of its initial genetic test for risk of opioid use disorder (OUD), SOLVD has won FDA approval for a revamped version of its DNA-based AvertD test.

The AvertD test, the first of its kind, is intended to be used prior to first exposure to oral opioid pain medications in patients being considered for treatment of acute pain, such as those scheduled to undergo a planned surgical procedure.

The FDA’s approval included requirements for training of healthcare providers “to help ensure appropriate use of the test” and that the company “conduct a large postmarket study assessing device performance in patients, regularly reporting progress made toward completion of that study to the FDA.”

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