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 ...
LINCOLN, Neb--(BUSINESS WIRE)--Celerion, a leading clinical research organization, proudly announces its recent achievement of obtaining the Clinical Laboratory Improvement Amendments (CLIA) ...
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 ...
In 2019, the first cases of SARS-CoV-2 were detected in Wuhan, China, and by early 2020 the first cases were identified in the United States. SARS-CoV-2 infections increased in the US causing many ...
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 ...
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, ...
Executive War College to Address, Clinical Laboratories’ and Genetic Testing Firms’ Perfect Storm, involving FDA’s Proposed LDT Rule, Payers Requiring Z-Codes on Genetic Test Claims, and Revisions to ...
According to MarketsandMarkets™, the Chemiluminescence Immunoassay Market is projected to grow from about USD 11.58 billion ...