JD Supra

Recent Updates to CLIA Proficiency Testing and Proposed Changes to Fees, Sanctions, and Other Requirements

To maintain the quality of laboratory testing, CLIA requires that laboratories performing moderate or high-complexity testing enroll in an approved proficiency testing program for independent ...

Zepto Life Technology Launches Plasma-Based FungiFlex(R) Mold Panel as CLIA Reference Laboratory Test

ST. PAUL, Minn., Jan. 21, 2026 /PRNewswire/ -- Zepto Life Technology has announced the launch of the FungiFlex (R) Mold Panel, a plasma-based molecular diagnostic test now available through its ...

Hickory, NC Urgent Care Adds On-Site CBC Testing to Support Timely Patient Care

HighER Level Urgent Care offers CBC testing enabled by CitoCBC®, a CLIA-waived blood analyzer designed for use in ...
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 ...
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 ...
Morningstar

Roche achieves first CLIA 'Moderate Complexity' categorization for Ionify® 25-Hydroxy Vitamin D total test

First mass spectrometry-based test system for total 25-Hydroxyvitamin D to receive CLIA 'Moderate Complexity' designation in the U.S. Expands access to advanced testing with a fully automated, ...
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 ...