Thursday, April 4, 2024

Rare Event: Experts Warn CMS and FDA Against a Test that FDA OK'd in December

In December, I wrote a blog abou the FDA approval of a PGx-based opioid use test, AvertD (here).  I noted there were a lot of oddities, including an FDA panel voting 11-2 against approval.  I noted that company presentations seemed to ask for de novo 510(k), but the approval was PMA, when it came a couple years later.

These particular chickens seem to have come home to roost.  A lengthy list of experts has submitted parallel letters to FDA and to CMS - asking CMS to revoke approval, asking CMS not to cover.

Coverage at Genomeweb is here:

Genomeweb notes that SOLVD is conducting post-approval studies, consults with thought leaders, and has a path ahead which is evidence-based solutions to the addiction crisis.

Coverage at STAT here.  Coverage at NBC here.  At HealthcareDive here.  At New York Times here.


The FDA letter is here:

The CMS letter is here:


AI Corner

Using only the two PDF letters, Claude.AI wrote a "news article" about the story.

FDA Approval of AvertD Genetic Test for Opioid Use Disorder Faces Backlash

In a highly unusual move, dozens of leading experts in genetics, addiction, psychiatry, and public health are calling on the U.S. Food and Drug Administration (FDA) to reverse its recent approval of AvertD, a genetic test that claims to predict risk for opioid use disorder (OUD). The experts have also urged the Centers for Medicare and Medicaid Services (CMS) to deny coverage for the controversial test.

The AvertD test, approved by the FDA in December 2023, analyzes 15 genetic variants to estimate a person's genetic risk for developing OUD. However, in an open letter to the FDA Commissioner and CMS Administrator, the 48 experts argue that the largest and most rigorous genetic studies show AvertD does not actually predict OUD risk.

"Current scientific knowledge about OUD genetics is strong enough for us to state that AvertD does not predict genetic risk of OUD," the experts write. They cite independent analyses showing that with proper controls for ancestry, the 15 variants provide no more predictive power than chance.

The experts raise serious concerns that false negative results could provide clinicians and patients with a "false sense of security" about opioid use, potentially exacerbating the opioid crisis through overprescribing. Conversely, they warn that false positive results could lead clinicians to withhold beneficial opioid treatment and cause patients to face discrimination due to being inaccurately labeled as prone to OUD.

Notably, the FDA's own advisory committee voted 11-2 against approving AvertD last year, with committee members expressing concerns about the test's lack of evidence and potential for harm from false results.

"FDA's decision to approve AvertD despite opposition from geneticists, other experts, and from its own advisory committee, was surprising," the letter states. "Ironically, FDA has touted its approval of AvertD as a step toward addressing the opioid crisis. We believe AvertD may make the opioid crisis worse."

Among the signatories are leaders in addiction medicine and genetics from prestigious institutions such as Johns Hopkins, Yale, Stanford, the University of Pennsylvania, and Columbia University. Also signing are the presidents of National Center for Health Research and Public Citizen's Health Research Group.

The strong pushback on AvertD's approval highlights ongoing concerns about insufficient scrutiny of genetic tests making unproven clinical claims. It remains to be seen whether the FDA or CMS will heed these experts' calls to reverse course on the controversial genetic test.

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