Business Wire

Sapient’s High Complexity CLIA Laboratory Receives Accreditation from the College of American Pathologists (CAP)

SAN DIEGO--(BUSINESS WIRE)--Sapient, a biomarker discovery organization providing bespoke services for metabolomics and lipidomics data generation and analysis, announced that its high complexity CLIA ...
JD Supra

FDA’s Proposed Rule for Oversight of Laboratory Developed Tests: Part II: FDA’s Proposed Phaseout Policy - Key Considerations & Open Questions

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 ...
Seeking Alpha

Roche achieves first CLIA 'Moderate Complexity' categorization for Ionify® 25-Hydroxy Vitamin D total test

First mass spectrometry-based test system for total 25-Hydroxyvitamin D to receive CLIA 'Moderate Complexity' designation in the U.S. Expands access to advanced testing with a fully automated, ...
inforum

Health officer's credential restores laboratory status at Fargo Cass Public Health

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 ...