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.
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