Monday, August 19, 2024

AMP Files Lawsuit Against FDA Over LDT Regulation

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On August 19, 2024, Association for Molecular Pathology (AMP) filed an 83-page legal case against the FDA and its regulation to govern lab-d...

CMMI's Terrible, Awful, Really Bad Day on the Hill

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The policy website, Policy and Medicine, covers a range of interesting topics.  Here, in its August 4 issue, it covers a recent House hearin...
Saturday, August 17, 2024

ARPA-H Launches "POSEIDON" - For a $100 MCED Test

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ARPA-H has launced a Poseidon Adventure of its own - an RFP that moves us toward developing a $100 MCED test.  It's in the news this wee...
Friday, August 16, 2024

CMS Press Release: MolDx Transplant LCD In Turnaround

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Update:  I didn't know, until September, there was a press release from CareDx discussing this on August 16.    It makes my point - MolD...

Heads Up: Illumina's Strategy Call (Aug 13); Decibio's Future of Sequencing Webinar (Aug 20)

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A reminder, a very interesting webinar from Decibio on August 20, 2024, looking at the future of NGS as a centralized or a distributed re...
Thursday, August 15, 2024

Ai Corner: AI Reviews the FDA Book, "Reputation and Power," 2010

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 In 2010, Harvard professor Daniel Carpenter published a landmark and widely-cited book, REPUTATION AND POWER , about the FDA and its contr...

Decibio's Cool Free Stuff: Here, Quarterly Update on Digital Health, AI

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Decibio provides industry-leading reports on sectors like genomics or digital health.  In addition, they provide significant open-access re...
Wednesday, August 14, 2024

Hofmarcher's Paper on Value of Precision Medicine: Lung Cancer (2023)

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Steven Haken is great for drawing attention to important recent papers.  This week, he also flagged Hofmarcher et al. (2023), a excellent p...

Denis Horgan's Paper on the European LDT Mess Caused by New Regulations

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 Last week, I cited the Horgan 2024 paper on the gap between medical guidelines and payor policy ( here ). This week, at Linked In, Steven H...
Tuesday, August 13, 2024

A New Article on Healthcare Policy in a Post-Chevron World (Includes ACLA FDA LDT Lawsuit)

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There was no shortage of reactions in the healthcare policy world, to the over-ruling of the "Chevron" principal in June.  (This b...
Sunday, August 11, 2024

Hansson et al 2022: A Remarkable "Case Study" for Anyone Accelerating Progress in Precision Medicine

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Header:  We often complain about the path to clinical adoption in precisoin medicine.   Alzheimer's biomarkers are booming with large sc...