[Histonet] LDT's Regulatiions by the FDA

[Jay Lundgren]

Seems to me they're going after immunos.  To my recollection, there are
only a very few kits that have FDA approval.  I would think it's going to
be more a manufacturer problem than a lab problem.  I doubt they would go
after the labs when they can go after Roche and Agilent (Ventana and
Dako).  But I could be wrong.

On Wed, Jun 26, 2024 at 3:41 PM Mac Donald, Jennifer via Histonet <
histonet at lists.utsouthwestern.edu> wrote:

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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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> I don't see the attachment.  Can you try again?
>
>
> 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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