Skip to main content
Premium Trial:

Request an Annual Quote

Experts Urge FDA, CMS to Revoke Approval, Coverage for Opioid Addiction Genetic Risk Test

This story has been updated to include statements from Solvd Health and the FDA.

NEW YORK – A coalition of geneticists, addiction experts, psychiatrists, and public health researchers on Thursday requested that the US Food and Drug Administration revoke its approval of AutoGenomics' AdvertD test for opioid use disorder (OUD), and that the US Centers for Medicare and Medicaid Services (CMS) deny it coverage.

Nonprofit patient advocacy group Physicians and Health Professionals for Responsible Opioid Prescribing (PROP) joined the other experts in making these requests via open letters to the respective agencies.

The FDA approved AdvertD late last year, citing an "urgent need for medical devices that can make a positive impact on the [opioid] overdose crisis." AutoGenomics was acquired in 2019 by Solvd Health, previously called Prescient Medicine.

AdvertD uses a cheek swab to detect 15 common single nucleotide polymorphisms (SNPs) that may be associated with higher risk for OUD. In their letters to CMS and the FDA, however, the PROP scientists wrote that the test "is based on an approach that has been abandoned by mainstream genetics," and that the "largest well-powered and state-of-the-art genome-wide studies of OUD 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."

The coalition further noted that an independent, peer-reviewed evaluation of AutoGenomics' claims with respect to AdvertD, found that the company's algorithm "fell into known pitfalls of genetic prediction" that give the appearance of predicting genetic risk, while actually performing no better than chance.

This, the experts argued, could lead to false negatives that would offer patients and their providers a false sense of security and false positives that could result in withholding opioids from patients may actually benefit from them.

"We believe AvertD may make the opioid crisis worse by contributing to overprescribing in patients who falsely test negative," the experts wrote.

In a separate statement, Solvd Health said that it has received and is reviewing the letters sent to the FDA and CMS.

"We believe the FDA approval of AvertD represents a significant step forward in helping clinicians and patients have informed discussions about opioid sparing techniques or alternative pain management options, if medically appropriate," the company wrote. "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."

The FDA also commented, writing by email that "given the totality of available evidence and the urgent need for medical devices that can make a positive impact on the overdose crisis, and specifically devices that can help assess the risk of developing [OUD], the FDA determined that there is a reasonable assurance of AvertD's safety and effectiveness, taking into consideration available alternatives, patients' perspectives, the public health need, and the ability to address uncertainty through the collection of post-market data. This approval represents another step forward in the FDA's efforts to prevent new cases of OUD, support the treatment of those with the disorder and decrease the misuse of opioid analgesics."

Solvd noted that it is currently conducting prospective post-market studies to evaluate AvertD’s performance in real-world settings and looks forward to working with the medical and patient advocacy communities with respect to AvertD's potential role in patient clinical risk assessments.

"Our path ahead fully aligns with Solvd Health's driving mission to find evidence-based solutions that can help prevent and mitigate OUD and its public health tolls," the company wrote.