FDA criticized for approval of genetic test for opioid addiction risk
Physicians and public health advocates are urging the US Food and Drug Administration (FDA) to revoke its approval of AvertD to predict the potential for opioid addiction and said the decision was based on methods that have been “abandoned” by mainstream genetics and could worsen the opioid crisis.The request was made in a 4 April letter to FDA Commissioner Robert Califf and signed by 31 public health stakeholders, researchers, and physicians.
FDA approved AutoGenomics’ AvertD in December 2023 as the first test to evaluate individual risk for developing opioid use disorder based on a DNA sample, despite an 11-2 vote against the test by the agency’s General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee in October 2022. (RELATED: This Week at FDA: year-end guidance drop, counterfeit Ozempic, and more, Regulatory Focus 22 December 2023). AutoGenomics is a unit of SOLVD Health.
“FDA’s decision to approve AvertD despite opposition from geneticists, other experts, and from its own advisory committee, was surprising,” said the letter.
AvertD detects 15 common single nucleotide polymorphisms (SNPs), and the test is based on an approach “that has been abandoned by mainstream genetics. The largest well-powered and state of-the-art genome-wide studies of OUD [opioid use disorder] to date demonstrate that even a full genome’s worth of markers (roughly 6,000,000) is not sufficient to predict OUD in a clinically useful way,” according to the letter.
“With proper controls for ancestry, genetic predictors from the 15 variants used in AvertD did not predict risk of OUD any better than chance,” said the letter. “The harmful consequences of an invalid genetic test for OUD are clear. Patients who test negative, and their clinicians, may have a false sense of security about use of opioids.”
The experts said the test used by the company to predict OUD was evaluated by geneticists who used a similar methodology as AvertD and found the algorithm to assess genetic risk was not a good indicator of generic risk. These findings were later published in a peer-reviewed journal.
FDA’s decision to approve the test was driven by its more activist approach in combating opioid addiction and substance misuse as part of its implementation of the FDA Overdose Prevention Framework. The test is meant to help drive physicians’ decisions regarding prescribing opioids.
SOLVD Health, in a statement, said the test was clinically validated and defended the approval decision. “Consistent with regulatory guidelines and standards, AvertD was clinically validated through a blinded, multi-center study evaluating participants at least one year after their initial exposure to prescription oral opioids. In the hands of physicians, the test results can be a critical tool to help combat opioid use disorder (OUD).”
The company said it is conducting prospective postmarketing studies to further assess the test’s performance in real-world settings.
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