111: FDA and LDT's what does it actually mean for the labs? Kitchen chat w/ Dr. Thomas Nifong

Send us a text What does the FDA jurisdiction for LDTs mean for the labs? Do they need to worry? How do they need to change the way they operate? In this episode, I talk with Dr. Thomas Nifong, a clinical pathologist and VP of CDX operations at Acrovan Therapeutics, about the recent FDA ruling on laboratory-developed tests (LDTs) issued on May 6th, 2024. We discuss the implications of considering LDTs as medical devices, requiring regulation, and explore the authority of FDA versus CLIA. The...