NORTHBROOK, Ill., Dec. 20, 2011 (GLOBE NEWSWIRE) -- Nanosphere, Inc. (Nasdaq:NSPH), a leader in the development and commercialization of advanced molecular diagnostics systems, announced today it has obtained CE IVD Mark under the European Directive on In Vitro Diagnostic Medical Devices for its Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) on the automated sample-to-result Verigene® System.
The BC-GP test expands Nanosphere's infectious disease test capabilities to include the rapid detection of bacteria that can cause deadly bloodstream infections. In a single automated test, the Verigene BC-GP test provides genus and species level detection for a broad panel of the most clinically significant gram-positive bacteria. The BC-GP test also detects several crucial markers for antibiotic resistance, including the mecA, vanA, and vanB genes. These genes can dangerously complicate the management of bloodstream infections by conferring resistance to the antibiotics methicillin/oxacillin and vancomycin.
"With the BC-GP test, clinicians treating patients suspected of deadly infections now have a first-of-its-kind diagnostic tool for detecting a broad array of disease-causing bacteria while simultaneously determining antibiotic resistance within the critical timeframe for making and adjusting initial treatment decisions," said Bill Athenson, Nanosphere's Vice President of International Sales and Marketing.
The BC-GP test provides identification of bacteria and resistance genes from gram-positive blood culture bottles within two and a half hours, as compared with current microbiological methods, which can take up to 2-3 days. Rapid and accurate identification of bacteria and resistance markers is critical in guiding appropriate antibiotic treatment. Studies have shown that delayed administration of appropriate antibiotics is associated with a 7.6% decrease in survival rate for each hour that therapy is delayed.1 Rapid molecular testing of blood cultures has been shown to reduce this time, and is associated with hospital cost savings of up to $21,000 per patient.2
The sample-to-result BC-GP test automates the steps of bacterial DNA extraction and target detection on the Verigene System. The ease-of-use and rapid turnaround time of the BC-GP test allow hospitals of any size to benefit from the speed and accuracy of automated molecular testing. In addition to its gram-positive blood culture test, Nanosphere is currently developing a test for gram-negative blood cultures that will provide genus, species, and resistance detection on the same automated platform. These tests complement a rapidly expanding test menu for infectious diseases that already includes the multiplexed Verigene RV+ respiratory virus test, and is expected to include CE-IVD tests for C. difficile and enteric pathogens in 2012.
About Bloodstream Infections
Septicemia is associated with millions of deaths each year worldwide. It is the primary cause of sepsis, which kills more people than lung cancer, breast cancer and colon cancer combined. Sepsis occurs when a pathogenic microorganism, usually a bacterium or a fungus, enters the bloodstream and causes an inflammatory immune response. Because bloodstream infections and septicemia are pervasive problems associated with high mortality rates, timely delivery of appropriate treatment is essential.
Bloodstream infections with gram-positive bacteria are often complicated by antimicrobial resistance. 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. Rapid identification of both organism and resistance is essential to implementing efficient and appropriate therapy.3
Gram-positive bacteria are also a common source of contamination during blood draws. Contaminant species are frequently responsible for false-positive blood cultures that lead to inappropriate antimicrobial use.4 Patients with contaminated blood culture bottles are often presumptively treated for bloodstream infections for several days until the organism can be identified as a contaminant using conventional biochemical methods. Due to the large burden of infections and contaminants from gram-positive bacteria, rapid identification of bacteria isolated from blood cultures is a primary healthcare concern.
About Nanosphere, Inc.
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.
The Nanosphere, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=4344
For additional information regarding Nanosphere's infectious disease products, please contact Nanosphere at IDtesting@nanosphere.us or visit www.nanosphere.us.
References
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Kumar A, Roberts D, Wood KE. Duration of hypotension before initiation of effective antimicrobial therapy is the critical determinant of survival in human septic shock. Crit Care Med. 2006;34(6):1589-1596.
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Bauer KA, West JE, Balada-Llasat J, Pancholi P, Stevenson KB, Goff DA. An antimicrobial stewardship program's impact with rapid polymerase chain reaction methicillin-resistant Staphylococcus aureus/S. aureus blood culture test in patients with S. aureus bacteremia. Clin Infect Dis. 2010;51(9):1074-80.
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Sahm DF, Free L, Smith C, Eveland M, Mundy LM. Rapid Characterization Schemes for Surveillance Isolates of Vancomycin-Resistant Enterococci. J Clin Microbiol. 1997;8:2026-2030.
- von Eiff C, Herrmann M, Peters G. Antimicrobial susceptibilities of Stomatococcus mucilaginosus and of Micrococcus spp. Antimicrob Ag Chemo. 1995;39:268-270.
* The BC-GP test is not available in the United States