We can now test for the risk of opioid use disorder

The FDA just approved a new tool in the fight against the opioid epidemic. But it’s not what you’d expect. 

This innovation is a simple DNA test.

Why this approach? Testing for the risk of developing opioid use disorder allows providers and researchers to attack this public health crisis from a different angle than most other existing interventions—such as overdose medications and harm reduction clinics. 

Let’s take a closer look at this new preventive care tool.

Illustration by Mary Delaney
Illustration by Mary Delaney

How did this DNA test come to be?

It’s been a long road so far for the first-ever opioid use disorder DNA test. The approval comes after an FDA advisory committee overwhelmingly voted no on an earlier version in October 2022.

The AvertD test was developed by Autogenomics (now acquired by SOLVD Health), which has worked with the FDA since the 2022 vote to modify the test. The approval now requires the company to train providers on how to use the test. They must also conduct a large post-market study to evaluate its performance, reporting results regularly back to the FDA.

So what are the biggest concerns about the test, which might have influenced the initial 2-11 denial vote?

The primary risks associated with AvertD are false negatives and positives. 

More information thanks to the test could help providers and patients make more calculated decisions about pain management care. However, inaccurate results could provide either a “false sense of security” or lead to unnecessarily inadequate pain management. In either of these scenarios, the stakes are high for patients.

Another challenge with this test is that the interplay of genetic factors is complex here—as with any condition where genetics play a partial role. The way the different genetic markers may factor into opioid use disorder can even manifest differently across demographic groups.

This complexity has led some to be skeptical of the test, like substance use epidemiology expert Dr. Katherine Keyes, a professor at the Columbia University Mailman School of Public Health.

“So the likelihood that a commercially developed genetic test for OUD would have the kind of validity that you would need to really drive clinical practice, based on the broader scientific literature, seems like a stretch,” she said. “If you just ask people, ‘Do you have a family history of addiction?’ I would hypothesize that that would be a better risk categorizer than this genetic test.”

This risk-benefit complexity is why AvertD’s required provider training will be so important for the test to be clinically helpful. Part of that training will emphasize that the test alone shouldn’t make or break a clinical decision—it should be one of many factors considered.

So, when is the test indicated?

Patients would take the test while considering a prescription for oral opioid pain medications, such as when recovering from surgery. This medical use of opioids is often where opioid use disorder patients’ troubles begin. Even short-term courses of opioid use can lead to addiction and, eventually, overdose. 

We’ve known for some time that genetics is a significant factor playing into addiction. For opioid addiction, the risk is generally greater for:

  • Women
  • Younger people in their teens or early twenties
  • People with a family history of addiction or substance misuse
  • People with mental illness such as major depression, anxiety, or PTSD

Patients eligible for the test are those 18 or older who both consent to it and have no prior use of oral opioid analgesics. For these patients, taking the test could help them and their providers make a more confident choice about whether their pain management regimen may put them at higher risk of opioid addiction. 

“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 to assess the risk of developing the disorder,” Dr. Jeff Shuren, director of the FDA’s 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 decrease the misuse of opioid analgesics.”

Of course, opioid use for medical pain management is not the only pathway to opioid addiction. Others suffering from this illness may have initially encountered the opioids recreationally—even taking doses from other patients who may be using the substances for medical purposes. 

In other words, this test isn’t a failsafe for testing the risk of everyone likely to take opioids. However, it’s an important decision-making tool as providers and public health officials seek to more tightly control which patients are prescribed opioids and why. 

It’s no magic bullet, but if it can even help a few patients avoid the tragedy of opioid use disorder, we consider that an important preventive health win.

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