Federal regulators have approved the use of a new DNA diagnostic tool that claims to predict the genetic risk for opioid use disorder (OUD).

The test uses a cheek swab and a proprietary algorithm to determine a test-taker’s genetic propensity for opioid addiction. According to an article in The Washington Post:

The Food and Drug Administration approved the AvertD cheek-swab test in December, despite an agency committee of experts voting overwhelmingly, 11-2, against recommending approval.

The article says research by the company shows that “patients identified by AvertD as having an elevated risk are 18 times more likely to develop an addiction after taking an opioid compared with people who take the test and are shown not to have an elevated risk.” That’s quite a difference.

The test is not recommended for predicting whether a person will develop opioid use disorder but for deciding whether to prescribe an opioid painkiller to a patient. The theory is the test will help cut down on opioid addiction by making fewer prescriptions to at-risk patients. The worry, however, is that it will lead to overprescribing based on a genetic test that one opioid researcher called “a sham.”

In a news release accompanying the approval announcement, the FDA recognized the risks of AvertD: “A false negative result could lead to a false sense of security for a patient who is at increased risk of OUD, and/or a health care provider.” The FDA insists that AvertD only be prescribed in connection with “a comprehensive clinical evaluation” including such things as interviewing the patient.

The algorithm used by AvertD has been “trained on genetic data from more than 7,000 people,” which does not sound like a lot. By comparison, the Rutgers Addiction Research Center at Rutgers University is working on its own genetic profiling for addiction that is based on genetic data from 1.5 million people.

Six million Americans suffer from opioid use disorder, resulting in an estimated 100,000 overdose deaths per year. It’s unclear whether this new DNA test will cause those numbers to go down or up.

Written by Steve O’Keefe. First published March 27, 2024.

Sources:

“DNA test says it can predict opioid addiction risk. Skeptics aren’t so sure.” The Washington Post, March 25, 2024.

“FDA Approves First Test to Help Identify Elevated Risk of Developing Opioid Use Disorder,” U.S. Food and Drug Administration, December 19, 2023.

Image Copyright: Den Store Danske, used under Creative Commons license.