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 ...
Business Wire

Celerion Achieves Milestone With CLIA Certification for Its Bioanalytical Laboratory, Expanding Capabilities in Clinical Trials and Diagnostic Testing

LINCOLN, Neb--(BUSINESS WIRE)--Celerion, a leading clinical research organization, proudly announces its recent achievement of obtaining the Clinical Laboratory Improvement Amendments (CLIA) ...
Nasdaq

Applied DNA Receives CLIA Certification, Enabling High Throughput Diagnostic COVID-19 Testing

STONY BROOK, N.Y.--(BUSINESS WIRE)-- Applied DNA Sciences, Inc. (NASDAQ: APDN) (Applied DNA or the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, today announced that ...
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 ...
RAPS

CLIA Waiver Decisions: FDA Begins Posting Summaries

The US Food and Drug Administration (FDA) on Friday began posting decision summaries for its Clinical Laboratory Improvement Amendments (CLIA) waiver decisions for in vitro diagnostics (IVDs) as part ...