Sunday, January 12, 2025

U Penn Study Finds Weak Results for FDA PMA Opioid Risk Test

A subscription article at Genomeweb on January 9 highlights:

FDA-Approved Opioid Use Disorder Risk Test Little Better Than Coin Toss, Study Finds

By Forest Ray, here.

I haven't studied the test so I don't have a personal viewpoint on it.  However, some of the fact patterns are interesting.

  • The test was approved by FDA with a prominent favorable press release from the FDA - December 19, 2023.
  • The test has the more sophisticated type of FDA device approval, a PMA approval, P230032B. (37pp).  Package insert (18pp).
    • I believe there was an FDA Ad Comm as well, along the way. See MedPage Today, October 2022.
  • By April 2024, the AvertD test saw negative press, e.g. at WBGH PBS here, or at Washington Post here.
  • The new paper at JAMA Network is Davis et al, here.

###