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The immunoassay, called the Elecsys CMV IgM, uses electrochemiluminescence to aid in diagnosing patients with cytomegalovirus infection.
The test provides conclusive visual confirmation of the presence or absence of lesions that could develop into cervical cancer if they are left untreated.
King's College London researchers reported that cardiac myosin-binding protein C might be more sensitive in detecting cell death due to a heart attack.
The Liat point of care system system has launched with four assays, including three respiratory tests and a novel test for Clostridium difficile.
The mySugr app will give Canadian users quick access to diabetes data and enable them to synchronize glucose levels with Roche's diabetes management system.
The test for cervical cancer screening previously received the IVD mark and US Food and Drug Administration approval on the Cobas 4800 system.
The companies are aiming to develop and commercialize a test to identify patients likely to respond to Loxo's cancer drug larotrectinib.
Molecular and point-of-care test revenues are showing promising growth in global diagnostics markets, but immunochemistry tests dominate overall.
The agency also cleared Roche's assay for diagnosing thyroid or pituitary disorders, as well as tests from Beckman Coulter, Immunostics, and BioMérieux.