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

Recent Updates to CLIA Proficiency Testing and Proposed Changes to Fees, Sanctions, and Other Requirements

To maintain the quality of laboratory testing, CLIA requires that laboratories performing moderate or high-complexity testing enroll in an approved proficiency testing program for independent ...
JD Supra

Unpacking Averages: Assessing FDA’s Performance Categorizing New Diagnostic Tests Under CLIA

This month’s post focuses on how timely FDA decisions are in categorizing new diagnostics under the Clinical Laboratory Improvements Amendments of 1988 (CLIA). The answer is that, on average, the ...
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, ...