Patients now have access to a prescription genetic test that could indicate their risk of opioid use disorder (OUD) before beginning treatment with an opioid pain medication.
The Food and Drug Administration (FDA) approved AvertD, the first test of its kind, on December 19. The test, manufactured by AutoGenomics, Inc., can be used before a 4-to-30-day prescription for pain medication, perhaps before a planned surgery.
The test is conducted by swabbing a patient’s cheek for a DNA sample which will show whether that individual matches the combination of genetic variants associated with OUD. The in vitro diagnostic test may give a false negative or false positive result.
AutoGenomics agreed to some modifications to its test when it sought pre-market approval in October 2022, which led to the FDA’s final decision.
“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 FDA said in a press release.
Addiction Is Complex
The genetic test could raise unnecessary red flags for patients seeking pain relief, says Jeffrey Singer, M.D., a surgeon, and senior fellow at the Cato Institute.
“I think the genetics of opioid use disorder are still not well-known,” said Singer. “While there are certainly some genomes that correlate with higher rates of opioid use disorder, genetics are only one of many correlates. Many people develop OUD without any genetic predisposition. On the other hand, most people with genetic predisposition don’t ever develop OUD,”
The most prevalent and consistent finding in people who go on to develop substance use disorder is a history of trauma during early developmental years, says Singer.
“It can be a single traumatic event or a cumulative series of events,” said Singer. “Also, roughly two-thirds of people who develop substance use disorder have psychoneurological comorbidities, such as autism spectrum, ADHD (attention deficit-hyperactivity disorder), and OCD (obsessive-compulsive disorder),” said Singer. “Then, there’s the matter of epigenetics: behavior and environment can affect the way genes express themselves.”
New information finds people with addiction disorder eventually outgrow it, says Singer. It is why researchers call addiction a behavior or learning disorder, not a physical disease.
“Bottom line: addiction is complex, and its causes are multifactorial. It can’t be approached with simple, cookie-cutter strategies,” said Singer.
Policy Concerns
Singer says patients should have access to the test like other medical products, but should discuss the results with an addiction specialist who could do a more comprehensive review.
“I worry that, as our policymakers are wont to do, they will lock on to the results of genetic screening tests and attach way too much significance to them than they should,” said Singer. “They will take the results of genetic screening tests in a vacuum without adding individual social context and all of the other risk factors that play a significant role in the development of substance use disorder.”
The screen may hold back health care providers from prescribing opioid pain medication, says Singer.
“(T)hey will be afraid of getting sued if a person for whom they prescribed an opioid develops an OUD after having tested positive on a screening test, even if they know that the screening test is only one very small piece of the opioid use disorder puzzle,” said Singer. “I worry that hospitals, health plans, and other facilities will misuse the test and require it before any patient can be prescribed opioids and, if the test is positive, deny patients adequate pain treatment.”
AnneMarie Schieber (amschieber@heartland.org) is the managing editor of Health Care News.
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