Healthcare company Nanosphere, Inc. (NSPH) Wednesday said it has obtained the CE IVD Mark, under the European Directive on In Vitro Diagnostic Medical Devices, for its Gram-Negative Blood Culture test or BC-GN on the automated sample-to-result Verigene System.
The CE IVD Mark is a requirement for in vitro diagnostic medical devices marketed in Europe.
The company said the test expands its infectious disease test capabilities to include rapid detection of bacteria that can cause deadly bloodstream infections. It further added that, with a single automated test, the Verigene BC-GN test provides rapid genus and species level detection for a broad panel of clinically significant gram-negative bacteria and also detects critical genetic markers of antimicrobial resistance, including KPC, NDM, CTX-M, OXA, VIM, and IMP.
Commenting on the development, Michael McGarrity, Nanosphere's Chief Executive Officer said, "The Gram-Negative Blood Culture test provides clinicians a revolutionary diagnostic tool for the simultaneous detection of disease-causing gram-negative bacteria and accompanying antibiotic resistance markers in a clinically actionable timeframe."
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