Nanosphere, Inc., a leader in the development and commercialization of advanced molecular diagnostics systems, announced today it 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.
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 (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. 1 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.
"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," said Michael McGarrity, Nanosphere's Chief Executive Officer.
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 2-3 days. The sample-to-result test automates the steps of bacterial DNA extraction, hybridization and target detection on the Verigene System. The ease-of-use and rapid turnaround time of the test allow hospitals of any size to benefit from the speed and accuracy of automated molecular testing.
The Gram-Negative Blood Culture test* complements Nanosphere's broadening menu of infectious disease tests including:
Gram-Positive Blood Culture test (BC-GP) to detect bacteria, including antibiotic resistance markers, that may cause bloodstream infections (510(k) cleared; CE Mark)
Respiratory Virus Plus test (RV+) to detect multiple respiratory viruses which cause respiratory tract infections (510(k) cleared; CE Mark)
Clostridium difficile test (CDF) to detect potentially deadly C. difficile and identifies the 027 hypervirulent strain (510(k) cleared; CE Mark)
Enteric Pathogens test (EP) to detect multiple bacteria, viruses and toxin genes which cause gastrointestinal infections (In Clinical Trials). Nanosphere plans to commercialize the Enteric Pathogens test in 2013 following receipt of the necessary regulatory approvals.
*The BC-GN test in not 510(k) cleared in the United States.