Criticism of FDA approval decision of the AvertD test to assess the elevated risk of developing opioid use disorder.- AutoGenomics/SOLVD Health

In December 2023, the FDA approved the AvertD test from AutoGenomics/SOLVD Health, to assess the elevated risk of developing opioid use disorder.

As SOLVD Health, prepares to rollout the AvertD test , prominent geneticists, public health researchers, and experts in addiction and device regulation are calling on the FDA to reverse itself and take AvertD off the market, saying that the test lacks a firm scientific foundation. They also are asking the Centers for Medicaid and Medicare Services not to pay for a test that they say does not work. In letters sent to the agencies ,31 scientists outlined a number of concerns with AvertD and how it was developed and tested, including that it analyzes just 15 genetic markers, which they say is woefully inadequate to reliably predict an individual’s risk of opioid use disorder, or OUD. Several large genetic studies have found that the associations between individual genes and OUD are so weak that even a score that took into account the 6 million variants addiction researchers have examined couldn’t accurately predict their risk of getting hooked on an opioid.

They also allege that it fails to take into account differences in geographic ancestry, which can skew results. An independent analysis conducted in 2021 found that algorithms attempting to predict opioid addiction using these 15 genetic markers performed “no better than a coin flip” after correcting for geographic ancestry. An inaccurate test could harm patients by providing a false sense of security about use of opioids to those who test negative, they warned, and potentially expose people who test positive to medical discrimination and stigma.