FDA Decision to Halt EUA Review of LDTs Raises Reimbursement, Liability Questions for Labs – 360Dx

Read article - Cites research by Gregory Tsongalis, professor of pathology and laboratory medicine, and director of clinical genomics and advanced technology, whose lab is working to develop a SARAS-CoV-2 LDT. He has been concerned that the FDA’s emergency use authorization standards have been too lax.