FDA approves test for opioid use disorder risk assessment

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The U.S. Food and Drug Administration (FDA) has approved a test designed to determine if a patient is at risk of developing opioid use disorder (OUD).

The prescription-use-only test, AvertD, was developed by AutoGenomics, a unit of SOLVD Health. The assay uses DNA collected from a cheek swab to determine if a combination of genetic variants associated with elevated risk of developing OUD is present.

The AvertD test is intended to be used in patients 18 and older who are being considered for a four- to 30-day prescription for oral opioid pain medications for the treatment of acute pain, e.g., in patients who are scheduled to undergo a surgical procedure. The test should be administered before the initial use of oral opioid painkillers, the FDA noted.

Additionally, the FDA states that AvertD is to be used in combination with thorough clinical evaluation and risk assessment. As part of the approval order, AutoGenomics must also provide training to healthcare providers to ensure the test’s appropriate use and conduct a post-market study to assess AvertD’s performance in patients, regularly reporting progress of that study to the FDA.

"Given the totality of available evidence and the urgent need for medical devices that can make a positive impact on the overdose crisis, and specifically devices that can help assess the risk of developing OUD, the FDA determined that there is a reasonable assurance of AvertD's safety and effectiveness, taking into consideration available alternatives, patients' perspectives, the public health need, and the ability to address uncertainty through the collection of post-market data," the agency said in its statement. “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.”

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