Yahoo Finance

Clinical Labs Review Proposed Legislation To Modernize Oversight of Lab-Developed Tests Under CLIA

SALT LAKE CITY, June 16, 2026 /PRNewswire/ -- Clinical laboratories, including ARUP Laboratories, are reviewing newly introduced federal legislation to modernize oversight of laboratory-developed ...
JD Supra

What the New CLIA Rules Mean for Labs and At-Home Testing

New regulations under the Clinical Laboratory Improvement Amendments (CLIA) introduced updated proficiency testing (PT) and PT referral rules that are now in effect. Although the regulations became ...
GlobalData on MSN

Co-Diagnostics files FDA 510(k) for flu and RSV PCR test

The molecular diagnostics company's concurrent CLIA Waiver by Application, if granted, would allow testing in decentralised ...
TMCnet

Co-Diagnostics Submits FDA 510(k) Premarket Notification for Upper Respiratory Point-of-Care Test

Submission includes a concurrent CLIA Waiver by Application for use of the test on the Co-Dx PCR Pro ® instrument in ...
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) ...

Allarity Therapeutics Announces CLIA Certification, Clearing the Path for Advancing DRP® Testing for FDA Registration

Allarity Therapeutics is now poised to run its DRP® testing in-house in a CLIA-certified laboratory environmentThe FDA requires that ...
Nature

Buildout of an automated high-throughput CLIA lab for SARS-CoV-2 testing on a large urban campus

In 2019, the first cases of SARS-CoV-2 were detected in Wuhan, China, and by early 2020 the first cases were identified in the United States. SARS-CoV-2 infections increased in the US causing many ...
GEN

TrovaGene to Buy MultiGen’s CLIA Lab to Bolster Infectious Disease Testing

Firm will configure MutliGen tests on transrenal platform. Molecular diagnostics firm TrovaGene is to acquire MultiGen Diagnostics’ CLIA-certified laboratory in return for 750,000 shares of TrovaGene ...
The Heritage Foundation

Lessons From COVID-19: How Policymakers Should Reform the Regulation of Clinical Testing

The onset of COVID-19 proved to be a real-time stress test of America’s clinical testing system. The experience exposed several flaws in the system that policymakers should address, specifically, ...
Business Wire

C₂N Opens State-of-the-Art CLIA Lab in St. Louis as Alzheimer’s Disease Blood Diagnostic Test Bests Others in Independent Comparison Studies Published in JAMA Neurology

ST. LOUIS--(BUSINESS WIRE)--On World Alzheimer’s Day, Missouri leaders and economic development officials praise C₂N Diagnostics for deciding to continue to grow its St. Louis-based company which is ...
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 ...
Yahoo Finance

Allarity Therapeutics Announces CLIA Certification, Clearing the Path for Advancing DRP® Testing for FDA Registration

TARPON SPRINGS, Fla., July 7, 2026 – Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib ...