FDA approves test for determining risk of opioid use disorder

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A new test for risk of opioid use disorder (OUD) could help counter the opioid overdose epidemic, “one of the most profound public health issues facing the United States,” according to the U.S. Food and Drug Administration (FDA).

AutoGenomics Inc. has gained FDA approval for its AvertD test to determine patients who may have an elevated risk of OUD. The test is meant to be used for adult patients before their first use of oral opioid pain medications for acute pain, for prescriptions lasting four to 30 days.

“AvertD may help patients who are concerned about being treated with an opioid for acute pain make better informed decisions,” said the Dec. 19, 2023, announcement from Jeff Shuren, MD, JD, director of the FDA Center for Devices and Radiological Health.

The test uses a DNA sample, taken by a swab of the cheek, to determine if a patient has the genetic variants associated with an elevated risk of developing OUD, according to FDA. The result should not be used in isolation, but should be part of a full clinical evaluation and risk assessment.

FDA ordered AutoGenomics Inc. to provide training to health care providers to ensure appropriate use of the test. The company also must study device performance in patients and report those results to the agency.

The primary risks of the test are false negative results that could lead to a false sense of security for patients and prescribers of opioid analgesics. False positive results could lead to inadequate pain management by avoiding opioids because of falsely identifying a patient as more susceptible to OUD. Those risks generally can be avoided through accurate labeling and training, with proper interpretation of test results and comprehensive risk assessments, according to FDA.

The approval process has taken more than a year, with an FDA advisory committee meeting in October 2022 before AutoGenomics submitted a Premarket Approval (PMA) application.

“The FDA recognizes that in premarket decision-making for devices, there generally exists some uncertainty around benefits and risks,” Shuren wrote. “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 PMA incorporates very precise conditions of approval, including mandating a post-approval study and the monitoring of test performance,” Shuren said.

In the last two years, FDA has offered guidance to address the drug overdose crisis and substance use disorder. The FDA Overdose Prevention Framework sets four priorities to address the opioid crisis as an evolving public health crisis.

This year, FDA approved the first nonprescription naloxone nasal spray in March and a generic version in July. FDA in July published draft guidance in “Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder.”