The FDA has approved the first test that checks a person’s DNA to see if they may have a genetic predisposition for and an elevated risk of developing opioid use disorder after their first exposure to prescription painkillers.
Developed by AutoGenomics and sponsored by SOLVD Health, the AvertD test received an agency green light under very narrow conditions: It should only be used by consenting adult patients who have no prior history of taking oral opioids, and only before they’re set to receive a multi-day regimen for treating acute pain—such as people who are scheduled to undergo surgery.
According to the FDA, the risks of over-relying on the test could be high: “A false negative result could lead to a false sense of security for a patient who is at increased risk of OUD,” said the agency’s device center director, Jeff Shuren. In addition, an incorrect result could push a healthcare provider to prescribe opioids to a patient when they otherwise would not.
A false positive, on the other hand, could lead to inadequate acute pain management by avoiding opioids altogether, Shuren said in the FDA’s announcement. The test is also not meant to be used in patients being treated for chronic pain.
Under the terms of the premarket approval, AutoGenomics must train healthcare providers on the appropriate use of its test, as well as conduct a large study on its real-world performance and report its findings to the agency.
“The FDA recognizes that in premarket decision-making for devices, there generally exists some uncertainty around benefits and risks,” Shuren said. “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 prescription-only lab test uses DNA taken from a cheek swab to search for a combination of 15 genetic variants that may be associated with an elevated risk of developing OUD.
A previous version of the AvertD test was examined by an FDA panel of outside experts in October 2022 while SOLVD Health was seeking a de novo clearance.
The advisory committee’s members voted 11-to-2 against whether AvertD’s risks outweighed its benefits, for reasons ranging from the test’s clinical study design to how its results could be misinterpreted by clinicians. Others cited uncertainty in the accuracy of its algorithms and in how the test’s genetic criteria would translate to a larger and more diverse real-world population.
According to Shuren, after the meeting, the agency worked with AutoGenomics to modify the test and put it through a more stringent premarket review. “The advisory committee’s feedback helped inform the FDA’s evaluation of the test and today’s decision, including the conditions for approval,” he said.
“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,” Shuren said.