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Nanosphere obtains CE IVD mark for Gram-Negative Blood Culture Test

Nanosphere announced 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 Gram-Negative Blood Culture test notably expands Nanosphere's infectious disease test capabilities to include rapid detection of bacteria that can cause deadly bloodstream infections, an increasingly recognized health threat. 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. The BC-GN test also detects critical genetic markers of antimicrobial resistance, including KPC, NDM, CTX-M, OXA, VIM, and IMP. These markers include carbapenem-resistant Enterobacteriaceae, or CRE, which are extremely difficult to treat bacteria that have become resistant to most antibiotics and can result in a 50% mortality rate in infected patients. Furthermore, the prevalence of these multi drug-resistant gram-negative bacteria is increasing worldwide. Fast and accurate detection of these antimicrobial resistance markers provides clinicians vital information to manage these often difficult-to-treat gram-negative bloodstream infections.