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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.
Antelope is currently developing a urine-based at-home test for the sexually transmitted infections Chlamydia trachomatis and Neisseria gonorrhoeae.
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 FDA cleared the point-of-care Binx io platform for the detection of chlamydia and gonorrhea in male urine specimens.
The company said clinical services revenues and diagnostic testing volumes rose during the quarter, but that PAMA continued to negatively affect reimbursements.
The assay detects 10 STIs and is performed on the molecular point-of-care Vivalytic platform, which was codeveloped by German company Bosch.
The GenFlex is a sample-to-result molecular diagnostic platform that includes sample collection, processing, amplification, and detection, the company said.
The new Series B investment was made by Northpond Ventures, with previously invested $20 million in the Australian diagnostics company.