Geneticists and addiction specialists are blasting the Food and Drug Administration for its recent approval of a genetic test, called AvertD, that claims to be able to show who’s at most risk for addiction to opioids.

“This is a test that the leading experts in the field of genetics believe does not work at all, that it really is a sham,” said Dr. Andrew Kolodny, the medical director for opioid policy research at Brandeis University.

“If we had such a genetic test, that might be a good thing,” Kolodny added. “Unfortunately, the test that the FDA just approved doesn't work. ... It's really no better than a coin flip when it comes to predicting risk of opioid addiction.”

Kolodny and 30 other scientists sent a letter to the FDA Thursday, asking the agency to rescind its approval of the test. The group sent a similar letter to the Centers for Medicare and Medicaid Services, urging that agency to deny coverage of the test when it is rolled out.

AvertD looks at 15 genetic variations that its makers say correlate to risk for opioid use disorder. But the scientists cite published research from 2021, saying that even the most comprehensive studies that look at millions of genomic markers have been insufficient to predict opioid use disorder in a clinically useful way.

“This test is based on an approach that has been abandoned by mainstream genetics,” the scientists said in their letters.

The group also points out that, during AvertD’s approval process, an advisory panel of independent experts voted 11-2 against FDA sanctioning the test.

The company that makes AvertD, SOLVD Health, said in a statement to GBH News that the test was “clinically validated through a blinded, multi-center study” and that they believe the it can be a critical tool for physicians.

“We are conducting prospective post-market studies to further evaluate the test’s performance in real-world settings and look forward to working with the medical and patient advocacy communities to advance the understanding of the important role AvertD can play as part of a patient’s clinical risk assessment,” the company said in its statement.

At the time of publishing, the FDA told GBH News that the agency was reviewing the letter's criticisms and would then share its response.

When the FDA announced its approval of AvertD in December of 2023, it touted it as part of its response to the opioid epidemic, saying it would “support the treatment of those with the disorder and decrease the misuse of opioid analgesics.”

But Kolodny said, “The reality is that, if anything, this test could make the opioid crisis worse.” He said most people do not have the 15 genetic markers the test looks for.

“Most people who take this test are going to test negative and be left with the impression that they don't have to worry about getting addicted,” Kolodny said, “and if they subsequently take opioids more aggressively for that reason, they are going to be more likely to get addicted.”

As for people who test positive, it could also pose dangers.

“Patients who ... believe that they're at higher risk for opioid addiction might not want to take opioids, even when they could benefit from them,” said Kolodny. “For example, a patient with metastatic cancer near the end of life who might be afraid of taking opioids.”

In Massachusetts, the opioid epidemic has killed about 2,000 people a year through overdoses for eight years now.