The FDA cleared a CellaVision test that provides differential counts of white blood cells, characterization of red blood cell morphology, and platelet estimations.
Following FDA's revocation of the firm's antibody-based test for the coronavirus in June, Chembio is seeking new EUAs for an antibody and antigen test for SARS-CoV-2.
Qiagen has benefited from unexpected tailwinds due to COVID-19 testing and envisions post-pandemic growth with recently acquired NeuMoDx as a key contributor.
Hologic received clearance for a change to a probe reagent in the Aptima Combo 2 assay to detect variants of Chlamydia trachomatis that have emerged recently.
The company said clinical services revenues and diagnostic testing volumes rose during the quarter, but that PAMA continued to negatively affect reimbursements.
The GenFlex is a sample-to-result molecular diagnostic platform that includes sample collection, processing, amplification, and detection, the company said.
