On Tuesday, the U.S. Food and Drug Administration approved a new genetic testing tool designed to assess the risk of developing opioid use disorder (OUD). The AutoGenomics AvertD test is intended for adults who are considering a short-term prescription of oral opioid pain medications, such as following surgery. This test is only for those who have never used opioids before, and patients must consent to the test. It is not meant for individuals with chronic pain.
Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, stated, “The opioid crisis is a major public health challenge in the U.S. and demands innovative approaches to prevent, diagnose, and treat opioid use disorder. This approval marks a significant step in the FDA’s efforts to reduce new cases of OUD, support current patients, and curb opioid misuse.”
Despite this, some experts express concerns about its clinical application, highlighting potential limitations and unintended consequences. The AvertD test analyzes 15 genetic markers related to addiction using a cheek swab sample, focusing on genes associated with the brain’s reward pathways.
Dr. Andrew Saxon, a professor at the University of Washington School of Medicine, notes that genetic factors influencing addiction are complex and involve multiple genes, not just one. Dr. Katherine Keyes from Columbia University points out that these genetic factors can vary significantly across different demographic groups, making them challenging to apply universally. She suggests that traditional methods, such as assessing family history of addiction, might be more reliable.
Relying heavily on the genetic test could lead to false negatives, potentially giving patients and providers a false sense of security about the risk of OUD, or false positives, which could unjustly limit access to necessary medications. This risk-benefit analysis was a key concern during the FDA advisory committee’s review of the test in October 2022, leading to a recommendation against its approval, which was later revised with conditions.
The FDA’s approval requires AutoGenomics to provide training for healthcare providers on the test’s use and conduct a large study to evaluate its post-market performance, with regular updates.
Dr. Shuren emphasized that while the test may help patients make more informed decisions about using opioids for acute pain, it should be part of a comprehensive clinical evaluation and not the sole factor in treatment decisions.
According to the U.S. Department of Health and Human Services, approximately 6 million Americans aged 12 and older had an opioid use disorder in 2022. The rise in drug overdose deaths, with opioids involved in about three-quarters of cases, underscores the need for careful consideration of opioid use. Last year, over 83,000 people died from opioid-related overdoses, as reported by the CDC.
Dr. Keyes cautions that while prescribed opioids are a significant risk factor for OUD, clinicians should review the literature and ensure they are comfortable with the safety and efficacy of new tools like the AvertD test.
