Focus Diagnostics, Inc has received 510(k) clearance from the U.S. Food and Drug Administration to market its two new Plexus EBV Multi-Analyte Diagnostics serology test kits for detecting the presence or absence of IgG and IgM antibodies in blood serum. The two tests are indicated as aids in the diagnosis of Epstein-Barr virus infection and EBV-associated infectious mononucleosis.
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Start-ups and the NCI pioneer novel technologies for disease detection
Read MoreOralDNA Labs, Inc, a new specialty diagnostics company focused on advancing existing and future laboratory diagnostic capabilities as they are applied within oral medicine, has been launched.
Read MoreAdvanDx, Woburn, Mass, reports that use of its PNA FISH test was associated with an 82% reduction in mortality rates from S. aureus bloodstream infections in the intensive care unit, a 53% reduction in overall mortality from staphylococcal bloodstream infections, and a significant reduction in antibiotic use, according to a new study published in the latest issue of the Journal of Therapeutics and Clinical Risk Management.
Read MoreBD Diagnostics, Franklin Lakes, NJ, reports the CE marking of the GeneOhm Cdiff molecular assay for the rapid diagnosis of patients with Clostridium difficile infection—and the company is seeking FDA clearance for the test.
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