The FDA has granted approval for the AvertD test, the first DNA-based test designed to assess an individual's genetic predisposition and heightened risk of developing opioid use disorder (OUD) after initial exposure to prescription painkillers.
Developed by AutoGenomics and sponsored by SOLVD Health, the approval comes with specific conditions: the test is restricted to consenting adult patients with no prior history of oral opioids, intended for use before receiving a multi-day regimen for acute pain treatment, such as pre-surgery.
The FDA acknowledges potential risks associated with the test, emphasizing that over-reliance could lead to false negatives, providing a misleading sense of security to patients at increased risk of OUD. Conversely, false positives might result in inadequate pain management by avoiding opioids entirely. Importantly, the AvertD test is not intended for patients undergoing chronic pain treatment.
Under premarket approval, AutoGenomics is required to train healthcare providers on the test's appropriate use and conduct a substantial study on its real-world performance, with findings reported to the FDA.
Despite uncertainties surrounding benefits and risks during premarket decision-making, the FDA recognizes the urgent need for devices addressing the opioid crisis. The AvertD test, by assessing the risk of OUD, was deemed to provide reasonable assurance of safety and effectiveness, considering available alternatives, patient perspectives, public health needs, and the ability to address uncertainty through post-market data collection.
The prescription-only test employs a cheek swab to analyze DNA, searching for 15 genetic variants associated with an increased risk of OUD.
An earlier version of the AvertD test faced scrutiny in October 2022 when an FDA panel reviewed it for de novo clearance. The committee voted 11-to-2 against the test, citing concerns about study design, potential misinterpretation of results by clinicians, uncertainty in algorithm accuracy, and applicability to a diverse real-world population.
Following the advisory committee's feedback, the FDA collaborated with AutoGenomics to enhance the test and subjected it to a more rigorous premarket review. The FDA's decision reflects a balanced consideration of benefits, risks, and the urgent need to address the opioid crisis.
The opioid crisis remains a significant public health challenge in the United States, necessitating innovative approaches for prevention, diagnosis, and treatment of opioid use disorder, including risk assessment measures. The approval of the AvertD test represents a step towards personalized interventions in combating the complex issues surrounding opioid addiction.
