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@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@lists.utsouthwestern.edu> > Sent: Tuesday, June 25, 2024 2:23 PM > To: histonet@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 > > > > > > > > _______________________________________________ > Histonet mailing list > Histonet@lists.utsouthwestern.edu > http://lists.utsouthwestern.edu/mailman/listinfo/histonet > > _______________________________________________ > Histonet mailing list > Histonet@lists.utsouthwestern.edu > http://lists.utsouthwestern.edu/mailman/listinfo/histonet > _______________________________________________ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
