After an over decade-long discourse amongst interested stakeholders, on October 3, 2023, FDA unveiled its proposed rule and policy to increase oversight over LDTs. If finalized as proposed, FDA would ...

A laboratory director of a nonwaived lab who holds a doctor of medicine (MD) or doctor of osteopathy (DO) degree must also be certified in anatomic pathology or clinical pathology, or both, by the ...

FAYETTEVILLE, Ark.--(BUSINESS WIRE)--Namida Lab, the world leader in tear-based diagnostics, today announced the launch of Auria™, a first-of-its-kind breast health assessment test. Backed by ...

For many years, success in the laboratory was defined primarily by analytical performance. While that remains essential, it ...

FARGO — Fargo Cass Public Health has a person certified to oversee higher level laboratory tests for patients for the first time in over a year. At the Board of Health meeting on Friday, Oct. 3, Fargo ...

Legacy Receives New York State CLEP Approval For Two Laboratory-Developed Tests: Semen Analysis And DNA Fragmentation. Legacy clears New York's stringent pre-market review of laboratory-developed ...

Food testing laboratories are facing increasing pressure to deliver fast, reliable, and defensible results across complex matrices. Expanding pesticide panels, stricter regulatory expectations, and ...