FDA urged to withdraw approval of opioid addiction genetic test

Public health doctors, geneticists and addiction specialists have signed a letter urging the US Food and Drug Administration (FDA) to withdraw its approval of a test for genetic susceptibility to opioid use disorder.

AvertD is a medical device that was approved by the FDA in December 2023 for use in patients who may require a short course of opioid painkillers, for example after surgery. It is intended only for people over the age of 18, who have never had opioids before, and is not intended for use in people with chronic pain. It involves a swab being taken from the inside of the cheek to collect DNA, to determine the presence of 15 genetic variants linked to genetic susceptibility to opioid use disorder. However, signatories of the letter point to research showing that the test does not predict risk 'any better than chance' when adjusted for ancestry.

'This test will make the opioid crisis worse,' Dr Andrew Kolodny, medical director of opioid policy research at Brandeis University in Massachusetts and signatory of the letter told NBC News.

'It will contribute to overprescribing, it will contribute to an increased incidence of opioid use disorder. In other words, more people becoming newly addicted to opioids.'

The letter has been signed by over 31 genetics, public health, addiction, regulation and medicinal device experts. They point to concerns about both over and under-prescribing of opioids as a result of using the test.

'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,' Dr Kolodny explained, 'and if they subsequently take opioids more aggressively for that reason, they are going to be more likely to get addicted'.

Whereas the opposite is also possible, and signatories warned that if patients are deemed at risk of opioid use disorder, they could be stigmatised and potentially face poorer health and social outcomes. Positive results could also result in practitioners refusing to prescribe opioids in cases when their use is necessary, depriving patients of the care they need. False positives were also a potential risk of using the test, they said.

In their letter, the experts cite multiple publications, including this study published in Drug and Alcohol Dependency, that support claims outlined in the letter, and urge the FDA to review them.