UPDATE - PUSHBACK - APRIL 2024 - https://www.discoveriesinhealthpolicy.com/2024/04/rare-event-experts-warn-cms-and-fda.html
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FDA has approved the first test to help identify elevated risk of opioid addiction, the AvertD test from AutoGenomics.
That's good news. But there's more - take a look at the FDA press release and the news reports, and there are a number of conditions.
The test requires physician education, is only to be used in the context of a clinical evaluation (e.g. nowhere near DTC), and the FDA wants postmarketing studies as well.
Find more here:
- FDA press release here.
- Company press here.
- I assume several paragraphs here, likely reflect the official indication and use labeling.
- Reuters here.
- Precision Medicine Online here.
- The Hill here.
- Update your Google search here (I think).
The project might tie in to a 2018 FDA initiative for new tests and technologies to fight the opioid crisis (here). FDA has a 2023 guidance devices [not drugs] to treat opioid use disorder, here.
FDA PROCESS - ADVISORY BOARD 2022
The FDA notes that "an earlier version of AvertD" was discussed at a October 2022 Ad Comm. The Ad Comm didn't seem to generate much press at the time, but is archived on YoutTube and the meeting documentation is online here. The FDA's questions to panel are here. The company's 79 page document on AvertD is here; it proposed a new version of a de novo classification.
The 18 page draft package insert is here. I wasn't sure what to expect from the FDA's meeting minutes, but they're pretty detailed at 26 pages here. (At some point, a PMA page will be created with a full final FDA safety and effectiveness review of 2023 for the final PMA. As of December 21, the last posted PMA device was September 29, so the S&E write-up may take 90 days.)
The FDA panel voted 11-2 against approval; a group that had published a negative article made public comment. For more detail see 26-page FDA summary (or see ten-point AI summary of it here.) See an AI comparison of the Sponsor vs FDA presentations here. See a primary 2021 publication about the test here.
See most of the FDA files in one cloud zip file here.
Noteworthy: the Ad Comm was set up against a de novo 510k; the final 2023 decision upgraded to a complicated PMA approval plan with conditions.
FDA and PMA Uncertainty
Per FDA, post-ad-comm revisions were collaborative between the company and the FDA. The FDA discusses the pathways that would occur if there was a false negative or false positive. The FDA specifically points to uncertainty about risks and benefits (e.g. the gap between what we know about clinical validity and what we'd like to know about clinical utility or real world evidence) - FDA on uncertainty here.
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AI CORNER
I hadn't heard of the 22 page Uncertainty Guide, so I asked Claude.AI for a 150 word summary:
Here is a 150 word summary of the key points from the FDA guidance document on considering uncertainty in benefit-risk determinations for medical devices:
The FDA guidance discusses how the agency considers uncertainty in making benefit-risk determinations to support premarket approval (PMA), De Novo classifications, and humanitarian device exemptions (HDEs) for medical devices. It notes there is inherent uncertainty in medical product safety and effectiveness.
The appropriate extent of uncertainty depends on factors like device type, intended use, available alternatives, and regulatory standards. More uncertainty may be acceptable for breakthrough devices addressing unmet needs or devices for small patient populations, with robust postmarket data collection to address uncertainty.
The guidance provides examples of how greater uncertainty could allow smaller premarket studies but require more postmarket evidence. Overall, marketing authorization depends on meeting statutory standards based on total valid evidence, considering uncertainty and using controls like labeling and postmarket surveillance when appropriate.
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Business Holdings. Fairly complicated; Autogenomics in Carlsbad CA was acquired in 2019 by Prescient Medicine Holdings, whereas the former company called Prescient Medicine Inc was renamed Solvd Health. Here. The various entities (Autogenomics, Prescient Holdings, and Solvd) all appear to be privately held. One public source available on Google suggests at one point Solvd had raised $120M.
You've heard of "prompt engineering" - the art of "talking to AI."
