Brief Blog: CAP and the FDA LDT Proposal: Two Notes

I wrote a  lengthy main blog and a number of "sidebar" blogs on the September 29 FDA proposal to regulate LDTs.

Here's some adjacent information from College of American Pathologists / CAP.  

Both topics are from their October 3, 2023, Advocacy Update and appeared as side by side bullets.

#1

CAP SEEKS 120 DAY COMMENT ON FDA LDT RULE  

Here's the top line section:

https://www.cap.org/advocacy/latest-news-and-practice-data/october-3-2023#story1

And here's the President's Letter on it.

https://newsroom.cap.org/latest-news/cap-seeks-120-day-comment-period-for-fda-proposal-on-the-oversight-of-ldts/s/497d5070-b336-4829-a68f-deecdc20a030? 

#2

CAP FINDS GENOMIC TESTS VERY ACCURATE

The second advocacy items the high accuracy of genetic tests, just publied in Archives of Pathology and Lab Medicine by Zehir et al.

News here:

https://newsroom.cap.org/latest-news/cap-molecular-proficiency-testing-programs-demonstrate-accurate-clinical-cancer-sequencing-results/s/affdda9c-1f18-4365-914a-e868876b32bc? 

And original article at APLM here:

https://meridian.allenpress.com/aplm/article/doi/10.5858/arpa.2023-0322-CP/496201/SPOT-Dx-Pilot-Reanalysis-and-College-of-American

###

I commented in my original blog that the FDA rulemaking (and online 127p supplement) quote dozens of articles, but don't pretend to be providing a systematic review, average, or meta-analysis.  

In some cases, a single (and perhaps cherry picked?) citation can be a key input to the FDA's speculative economic projections of tens of billions in costs (real costs) or especially the hundreds of billions of dollars in benefits (which are virtual or imputed life-year quality benefits).