Nanosphere obtains CE Mark for Gram-negative blood culture test

March 21, 2013

Nanosphere, Inc., developer of advanced molecular diagnostics systems, has obtained the CE IVD Mark under the European Directive on In Vitro Diagnostic Medical Devices for its Gram-Negative Blood Culture test (BC-GN) on the automated sample-to-result Verigene System. Clinical trials are also underway for an FDA submission.

The Gram-Negative Blood Culture test expands Nanosphere’s infectious disease test capabilities to include rapid detection of bacteria that can cause deadly bloodstream infections. 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 (CRE). Fast and accurate detection of these antimicrobial resistance markers provides clinicians vital information to manage these often difficult-to-treat Gram-negative bloodstream infections.

The BC-GN test provides identification of bacteria and resistance genes from Gram-negative blood culture bottles in less than two hours, as compared with current microbiological methods, which can take up to two-to-three days. The sample-to-result test automates the steps of bacterial DNA extraction, hybridization, and target detection on the Verigene System. Hospitals of any size can benefit from the speed and accuracy of automated molecular testing.

The Gram-Negative Blood Culture test complements Nanosphere’s menu of infectious disease tests including its Gram-Positive Blood Culture test (BC-GP); Respiratory Virus Plus test (RV+); C. difficile test (CDF); and Enteric Pathogens test (EP) to detect multiple bacteria, viruses and toxin genes which cause gastrointestinal infections (in clinical trials). Read more about Nanosphere’s Gram-Negative Blood Culture test.