The US Food and Drug Administration approved a new tool Tuesday that uses genetic testing to help diagnose whether certain people are at risk of developing an opioid use disorder.
The AutoGenomics AvertD test is for adults who are considering a short course of oral opioid pain medications, such as after a planned surgical procedure. It can only be prescribed to people with no prior use of opioids, and patients must consent to testing. It is not for those being treated for chronic illness.
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 assessing the risk of developing the disorder, Dr. Jeff Shuren, director of the FDA Center for Devices and Radiological Health, said in a statement. This approval represents another step forward in the FDA’s efforts to prevent new cases of OUD, support the treatment of those with the disorder and reduce the misuse of opioid analgesics.
However, some experts are skeptical about its use in clinical practice and caution that some of its limitations may have dangerous unintended consequences.
The AvertD test uses a sample from a cheek swab to analyze 15 genetic markers involved in the brains reward pathways and associated with addiction.
But genetics is a complicated trade, says Dr. Andrew Saxon, a professor of psychiatry and behavioral sciences at the University of Washington School of Medicine. It’s not simple Mendelian inheritance where one gene has a mutation and gives you opioid use disorder. It’s many different genes, all contributing to this effect.
And there is evidence that these factors can manifest at different levels in demographic groups, which can make them difficult to identify 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’d need to really drive clinical practice, based on the broader scientific literature, seems like a stretch, he says. . If you just ask people, Do you have a family history of addiction? I would hypothesize that that is a better categorizer of risk than this genetic test.
Even asking a patient about their history of substance use, especially tobacco use, can be just as insightful, Saxon said.
If the genetic test is too reliable, a false negative test result may give patients and their providers an increased sense of security about their risk of developing an opioid use disorder, and a false positive may limit a patient’s access to beneficial drugs.
This risk-benefit analysis was at the heart of a discussion about the test at an FDA advisory committee meeting in October 2022, and the independent panel ultimately recommended against it in an 11-2 vote.
The FDA subsequently worked with AutoGenomics as it revised the test. Terms of the new approval require the company to provide training to health care providers on the appropriate use of the test and conduct a large study assessing post-market performance with regular reports of development.
Information from the test could help patients worried about being treated with an opioid for acute pain make more informed decisions, Shuren said. This information should be used as part of a complete clinical evaluation and risk assessment; it should not be used alone to make treatment decisions.
About 6 million people in the US aged 12 and older will have an opioid use disorder in 2022, according to recent survey data from the US Department of Health and Human Services. And drug overdose deaths have risen in recent years, with opioids involved nearly three-quarters of the time. More than 83,000 people died from overdoses involving an opioid last year, according to data from the US Centers for Disease Control and Prevention.
I still think that prescription opioids remain a known risk factor for developing opioid use disorder, Keyes said. I just encourage clinicians to look at the literature and make sure they are comfortable with the level of safety of the product.
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