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Siemens Healthineers got the nod for its Advia Centaur CA 125 II Assay for detecting CA 125 to help in the management of patients with ovarian carcinoma.
The firm expects to ship more than 25 million antibody-based serology tests for use on its Advia Centaur and Atellica immunoassay platforms by the end of May.
The company had received CE marking for the test in April, allowing for its use as a clinical diagnostic test in Europe.
The firm said it anticipates introducing an antibody test for its high-throughput analyzers that will detect an immune response to the coronavirus.
The company plans to ship more than 1.3 million tests per month worldwide as production capacity increases in May.
BioMérieux's BioFire received clearance for its Blood Culture Identification 2 Panel for the identification of nucleic acids associated with bacteria and yeast.
The firm believes that its molecular assay for the laboratory will help ease some of the supply chain issues hampering test rollout during the pandemic.
The analyzer supports COVID-19 response efforts, where blood-gas testing plays a critical role in monitoring patients' respiratory distress, the firm said.
Abbott received five separate clearances associated with its i-Stat Chem8+ cartridge running on the company's iStat 1 system.
DiaSorin got the nod for the Liaison Lyme Total Antibody Plus assay which uses chemiluminescence to detect lgG and IgM antibodies to Borrelia burgdorferi.