[Histonet] LDT's Regulatiions by the FDA

[Mac Donald, Jennifer]

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-----Original Message-----
From: Histology via Histonet <histonet at lists.utsouthwestern.edu>
Sent: Wednesday, June 26, 2024 8:13 AM
To: Paula <plucas at biopath.org>; histonet at lists.utsouthwestern.edu
Subject: Re: [Histonet] LDT's Regulatiions by the FDA

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Mehndi Helgren
Lab Manager
757-664-7901
Dominion Pathology Labs.
733 Boush St. Suite 200
Norfolk, VA  23510



-----Original Message-----
From: Paula via Histonet <histonet at lists.utsouthwestern.edu>
Sent: Tuesday, June 25, 2024 2:23 PM
To: histonet at lists.utsouthwestern.edu
Subject: [Histonet] LDT's Regulatiions by the FDA

Hello,



Has anyone read about the new regulations for the LDTs (Laboratory Developed
Tests) that were passed by the FDA?

Does anyone have any comments about it?

If the new LDT requirements by the FDA don't get overturned, we are looking at a lot of paperwork, labor, and consulting/attorney expenses for running IHC's in 2025 and forward.



I've attached an article in the June issue of Laboratory Economics for your reference. The subject starts on page 1, then continues to pages 3 and 4.



Thank you,

Paula Lucas

Lab Manager

Bio-Path Medical Group







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