Science behind genetic testing for identifying risk of opioid misuse remains unproven

A new report from researchers at the Perelman School of Medicine and Crescenz VA Medical Center has evaluated a genetic test for opioid use disorder that recently received pre-marketing approval by the FDA, finding that the genes comprising it do not accurately identify individuals likely to develop the disorder.

Opioid misuse and specifically opioid use disorder (OUD), continues to represent a significant U.S. public health threat, with more than 6 million Americans aged 12 and older meeting the criteria for OUD in 2022. Efforts to ease the crisis have included the development of genetic testing to identify individuals most at risk for OUD.

A scientist with a pipette and a test tube with a computer screen in the background.
Image: iStock/Cavan Images

New research published in JAMA Network Open questions the usefulness of 15 genetic variants from an algorithm meant to predict OUD risk that was recently granted pre-marketing approval by the Food and Drug Administration. It found that the testing could lead to both false positive and false negative results.

The study was led by Christal Davis, a postdoctoral fellow at the Philadelphia-based Crescenz VA Medical Center and Henry Kranzler, a professor of psychiatry and the director of the Center for Studies of Addiction.

“These findings underscore the need for more robust and complete data, particularly given the complex nature of psychiatric conditions, including OUD,” Kranzler says. “The potential harms deriving from a faulty genetic test for OUD include both false negatives and false positives.”

Read more at Penn Medicine News.