Thursday, December 7, 2023

Reagan-Udall Foundation Report on Real World Evidence Generation, PostMarket, FDA

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Last week was the 17th annual meeting of the Personalized Medicine Coalition (PMC), which has also posted talks on its public YouTube channe...

Several Physicians, CFO, Tagged with Nearly $1M in DOJ Lab Penalties

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We regularly read of large penalties assessed against corporations or against laboratory owners for lab inducement or fraud. I mention the p...

Adaptive Biotechnologies Features 30 Abstracts on MDR

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 While news reports highlight a slowdown in tech funding relative to 2020-2021 ( NYT here  today), many sciences of vibrant progress in fiel...
Wednesday, December 6, 2023

CAP Today November 2023: Bonanza of Interesting Articles

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 Given that headline, I should probably add that all the articles in CAP TODAY are likely interesting to somebody , somewhere.  But this is...
Tuesday, December 5, 2023

AMA Genomic Workgroups Continue (A: Dec 6, Jan 8; B: Dec 18, Jan 23)

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The AMA is in its third year of running publicly available workgroups that plan consensus code revisions for genomic tests , such as heredit...
Monday, December 4, 2023

ACLA Comment to FDA…it Includes MolDx!

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ACLA announced that it has submitted a detailed, 107-page comment letter to the FDA, in response to the FDA's proposal to regulate lab d...

MolDx Covers MRD Test for Head and Neck - Based on Circulating HPV DNA

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MolDx has granted coverage under its "Minimal Residual Disease" LCD, for monitoring head and neck cancer. There's a twist.  Mo...

ACLA Issues 107-Page Comment Against FDA Regulation of LDTs

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The ACLA issued a 107-page comment letter that urges the FDA to drop its present proposal to rapidly regulate lab developed tests usings it...
Sunday, December 3, 2023

FDA, Multi-Cancer Screening, and Mortality? Consider Three Additional Points

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 As we move towards an era of blood-based multi-cancer screening, there have been arguments that adoption must follow overall mortality bene...
Friday, December 1, 2023

Five Interesting Law Firm Essays about FDA LDT Proposals

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In the last couple weeks, I ran across a number of interesting articles from law firms about the FDA proposal to regulate lab developed test...
Wednesday, November 29, 2023

NEJM Op Ed Tackles CMS Efforts to Modernize Coverage Policy

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  A policy opinion piece in the November 30, 2023 NEJM, by Kadakia et al., provides a fairly detailed overview of coverage problems at CMS, ...
Tuesday, November 28, 2023

New Alzheimer Codes Dominate Lab Agenda for AMA CPT Feb 2024

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Registration is open for the February 1-3, 2024, AMA CPT Editorial Meeting in San Diego.  Registration may be both in person or virtual.  He...

FDA Posts Agenda and Questions for MCED Panel November 29, 2023

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On November 29, 2023, FDA is holding     ^held   an all-day panel on how the FDA should plan for trials and evaluations of MCED, multi cance...
Monday, November 27, 2023

NEJM AI: With Complex Cases, GPT-4 Usually Beats Humans (Eriksen et al.)

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Last April, NEJM announced it would launch ai.NEJM, a new AI-focused journal (see coverage at MedPageToday ).  At the time, it publishes Lee...
Sunday, November 26, 2023

MolDxOlogy - Payments for 2022 Category 1 Genomic Codes, by MAC

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Header:  Of Category I genomic CPT codes, about 65% MolDx payments, 20% NGS MAC, 15% Novitas.  But, most NGS MAC payments represented Cologu...