[Histonet] LDT's Regulatiions by the FDA

[Paula]

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