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 ...
Crown Bioscience, a global contract research organization (CRO) and a JSR Life Sciences company, today announced that its San ...
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 ...
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 ...
The CLIA-waived CitoCBC® expands patient access to quick CBC results in physician offices, pharmacies, and home care, enabling data-driven diagnostics. CBC is one of the most commonly requested lab ...
Gene Solutions, a global biotechnology company, and Pangea Laboratory, a CLIA-certified, CAP-accredited Next Generation Sequencing (NGS) leader in validation platforms for Laboratory Developed Tests ...
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 ...
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 ...
There are two organizations that play a complementary role in ensuring regulatory compliance in laboratory diagnostics and the development of at-home diagnostics. The Food and Drug Administration (FDA ...
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