[Histonet] LDT's Regulatiions by the FDA

[Jay Lundgren]

Can I ask you to provide an example of a laboratory developed test?  So
we're all on the same page.
A test that you are not buying from a vendor, but just a totally in house
protocol, reagents, etc?
Using a vendor's test kit off label?
Would a simple special stain like a PAS qualify as a LDT if you are making
your own reagents and using the AFIP manual for a protocol?
If you, for instance, tweak your PAMS impregnation time because one
pathologist likes his a little darker, is that an LDT?

Sincerely,

Jay A. Lundgren, M.S., HTL (ASCP)

On Wed, Jun 26, 2024 at 10:22 AM Histology via Histonet <
histonet at lists.utsouthwestern.edu> wrote:

> 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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