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 ...
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 ...

Cizzle Bio Announces Laboratory Validation of CIZ1B Biomarker Blood Test for Early Lung Cancer at OmniHealth Diagnostics

Cizzle Bio, Inc., a Texas-based biotechnology company advancing biomarker blood tests for early detection of lung and gastric cancers, today announced the laboratory validation of its proprietary ...
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 ...
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

Amid National Surge in Sexually Transmitted Infections binx health Announces Launch of Reagent Rental Program for Decentralized, Rapid, Point-of-Care Testing Platform for ...

BOSTON--(BUSINESS WIRE)--binx health, a healthcare technology and women’s health company focused on making routine testing broadly accessible and convenient, announced today the launch of its ...