WEST LAFAYETTE, Ind. — Amplified Sciences, a clinical-stage life sciences diagnostic company that develops tests for early, more accurate detection of challenging diseases, starting with pancreatic ...
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 ...
CPT copyright 2010 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. The Food and Drug ...
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 ...
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 ...
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 ...
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 ...
CMS has issued a final rule that gives the agency greater discretion in enforcing the Clinical Laboratory Improvement Amendments, according to the Taking Essential Steps for Testing Act of 2012. Under ...
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, ...
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