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 ...
Yahoo Finance

Zepto Life Technology Launches Plasma-Based FungiFlex® Mold Panel as CLIA Reference Laboratory Test

The FungiFlex ® Mold Panel detects cell-free DNA (cfDNA), small fragments of fungal DNA circulating in the bloodstream, from a single plasma sample and is designed to identify 14 clinically important ...
Becker's Hospital Review

FDA approves 1st COVID-19 test cleared with CLIA waiver

The FDA cleared for commercial distribution a diagnostic panel that tests for multiple respiratory viral and bacterial infections on Feb. 3. The BioFire Spotfire Respiratory Panel is the first ...
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, ...
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 ...