Nanosphere Obtains CE Mark for Gram-Negative Blood Culture Test
First-of-Its-Kind Comprehensive Sample-to-Result Test for Simultaneously Detecting Potentially Deadly Gram-Negative Bacteria and Antimicrobial Resistance Markers Enables Clinicians to Accelerate Delivery of Appropriate Antibiotic Treatment in Potentially Life Threatening Bloodstream Infections and Septicemia Which Are Associated With High Mortality Rates Expands Menu of Infectious Disease Tests on Nanosphere's Sample to Result Verigene® System
(firmenpresse) - NORTHBROOK, IL -- (Marketwire) -- 03/13/13 -- Nanosphere, Inc. (NASDAQ: NSPH), 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
Bloodstream infections occur when a pathogenic microorganism, usually a bacterium or a fungus, enters the bloodstream and causes an inflammatory immune response. Because bloodstream infections are pervasive problems associated with high mortality rates, timely delivery of appropriate treatment is essential. Studies have revealed that delayed administration of appropriate antibiotics is associated with a 7.6% decrease in survival rate for each hour appropriate therapy is delayed.(2) The inability to rapidly identify resistant strains of pathogenic bacteria has led to antimicrobial use that is often ineffectual, wasteful, or bears risk of proliferating resistant strains.
According to the European Centre for Disease Control and Prevention (ECDC), 3.9% of patients staying more than 2 days in intensive care units throughout Europe acquire bloodstream infections, roughly 4.2 bloodstream infections per 1,000 patient days.(3) The ICU mortality in patients with ICU-acquired bloodstream infections is 33.2%, which is 2.4 times higher than for patients without bloodstream infections.(3) In addition, the length of stay in the ICU for patients that acquire bloodstream infections is approximately 3.5 times higher than for patients without bloodstream infections.(3)
Bloodstream infections with gram-negative bacteria are often complicated by antimicrobial resistance. Resistance rates are increasing among several problematic gram-negative pathogens that are often responsible for serious nosocomial infections including Acinetobacter, Pseudomonas aeruginosa, and Enterobacteriaceae. The presence of multi drug-resistant strains in these organisms has been associated with prolonged hospital stays, higher health care costs, and increased mortality.(4) New antimicrobial resistant mechanisms will continue to evolve leading to more multi drug-resistant gram-negative bacteria, which clinicians will have little to no antibiotic weapons for treatment.
The CE IVD Mark is a requirement for in vitro diagnostic medical devices marketed in Europe. It is a declaration by the manufacturer that the product meets all the appropriate provisions of the relevant legislation including those relating to safety. The CE IVD mark is recognized throughout the 27 EU member states as well as in Norway, Iceland and Liechtenstein. Products with the CE IVD Mark can be freely marketed anywhere in the EU without further control. In addition, it is generally seen as an important benchmark for product adoption in countries outside the EU.
Nanosphere develops, manufactures and markets an advanced molecular diagnostics platform, the Verigene System, for multiplexed infectious disease, genetic, and ultra-sensitive protein testing. This easy-to-use platform offers laboratories a convenient, simple, and cost-effective solution for highly sensitive nucleic acid and protein testing. Nanosphere is based in Northbrook, IL.
For additional information regarding Nanosphere's infectious disease products, please contact Nanosphere at or visit .
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Nanosphere, Inc.
Roger Moody
847-400-9021
Chief Financial Officer
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Michael Rice
LifeSci Advisors, LLC
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Datum: 13.03.2013 - 12:00 Uhr
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