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

Clinical laboratories, including ARUP Laboratories, are reviewing newly introduced federal legislation to modernize oversight ...
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 ...
Business Wire

Executive War College to Address, Clinical Laboratories’ and Genetic Testing Firms’ Perfect Storm, involving FDA’s Proposed LDT Rule, Payers Requiring Z-Codes on Genetic ...

Executive War College to Address, Clinical Laboratories’ and Genetic Testing Firms’ Perfect Storm, involving FDA’s Proposed LDT Rule, Payers Requiring Z-Codes on Genetic Test Claims, and Revisions to ...
Nasdaq

QuidelOrtho's (QDEL) Rapid Antigen Test Gets CLIA Waiver

QuidelOrtho Corporation QDEL recently announced that it has been granted a CLIA Waiver by the FDA, which applies to its new Sofia 2 SARS Antigen+ FIA (fluorescent immunoassay). The Sofia 2 SARS ...
abc27

Avance Biosciences™ Registers with CLIA, Expanding Clinical Trial Testing Capabilities

HOUSTON, Feb. 26, 2025 /PRNewswire/ -- Avance Biosciences, a leading provider of high-quality analytical and bioanalytical services for the pharmaceutical industry, is pleased to announce that it has ...
Nasdaq

Axim Biotechnologies Files Pre-Submission With FDA for CLIA Waiver Pathway on Lactoferrin Point-of-Care Diagnostic Test

SAN DIEGO, CA - June 24, 2025 (NEWMEDIAWIRE) - Axim Biotechnologies, Inc. (OTCQB: AXIM), a leading developer of rapid diagnostic testing for ocular and systemic conditions, today announced that it has ...
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) ...
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 ...