On March 30, the CDC announced that a host of tests are “offline” for illnesses like rabies, Epstein Barr, herpes, influenza, ...

LINCOLN, Neb--(BUSINESS WIRE)--Celerion, a leading clinical research organization, proudly announces its recent achievement of obtaining the Clinical Laboratory Improvement Amendments (CLIA) ...

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 ...

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 ...

Following its milestone CLIA waiver clearance for its FebriDx® rapid point-of-care test and the completion of a placement, ...

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 ...

High Expression of FGD3, a Putative Regulator of Cell Morphology and Motility, Is Prognostic of Favorable Outcome in Multiple Cancers In all, 142 (95%) of 150 questionnaires were completed by 38 ...