The U.S. Food and Drug Administration on Tuesday approved a new tool that uses genetic testing to assess whether certain people are at risk for opioid use disorder.
The AutoGenomics AvertD test is intended for adults who are considering short-term oral opioid pain medication, such as after a planned surgical procedure. It can only be prescribed to people who have not used opioids before, and patients must agree to the test. It is not intended for those receiving treatment for chronic pain.
The opioid crisis, one of the most profound public health problems in the United States, requires innovative measures to prevent, diagnose and treat opioid use disorder, including assessing the risk of developing the disorder, Dr. Jeff Shuren, director of the FDA’s Center for Device and Radiological Health, said in a statement. This approval is another step forward in the FDA’s efforts to prevent new cases of OUD, support treatment for those with the disorder, and reduce opioid pain medication abuse.
However, some experts are skeptical about its use in clinical practice, warning that some of its limitations could have dangerous unintended consequences.
The AvertD test uses a swab sample to analyze 15 genetic markers linked to the brain’s reward pathways and linked to addiction.
But genetics is a complicated business, noted Dr. Andrew Saxon, a professor of psychiatry and behavioral sciences at the University of Washington School of Medicine. It is not a simple Mendelian inheritance where there is a mutation in one gene that causes opioid use disorder. It has numerous different genes that all contribute to this effect.
And there is evidence that these factors can occur to varying degrees in different populations, which can make it difficult to identify them in population samples, said Dr. Katherine Keyes, a professor at the Columbia University Mailman School of Public Health whose research focuses on psychiatric and substance use epidemiology.
So the likelihood that a commercially developed genetic test for OUD would have the kind of validity you need to guide clinical practice based on the larger scientific literature seems like a stretch, he said. If you just ask people: Do you have addiction in your family? I would assume that would be a better Risk Rating than this genetic test.
Even asking a patient about their substance use history, especially tobacco use, could be just as insightful, Saxon said.
If genetic testing is over-relied, a false-negative result can give patients and their providers a high sense of security about their risk of developing an opioid use disorder, and a false-positive result can limit a patient’s access to helpful medications.
That risk-benefit analysis was at the heart of the debate over the test at an FDA advisory committee meeting in October 2022, and the independent panel ultimately recommended against it by an 11-2 vote.
The FDA later worked with AutoGenomics as it modified the test. The terms of the new approval require the company to train healthcare providers on the appropriate use of the test and conduct an extensive study evaluating post-marketing performance with regular progress reports.
Information from the test could help patients concerned about opioid therapy for acute pain make better informed decisions, Shuren said. This information should be used as part of a full clinical evaluation and risk assessment; it should not be used alone to make treatment decisions.
About 6 million people in the U.S. aged 12 and older will have an opioid use disorder in 2022, according to a recent study by the U.S. Department of Health and Human Services. And drug overdose deaths have increased in recent years, with opioids accounting for about three-quarters of the time. More than 83,000 people died of opioid overdoses last year, according to the US Centers for Disease Control and Prevention.
I still believe that prescribed opioids remain a significant risk factor for developing opioid use disorder, Keyes said. I just encourage clinicians to review the literature and make sure they are comfortable with the level of safety of the product.
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