Nanosphere Receives FDA Clearance of Gram-Positive Blood Culture Test for Staphylococcus
NORTHBROOK, Ill., Dec. 27, 2011 (GLOBE NEWSWIRE) -- Nanosphere, Inc. (NSPH), a leader in the development and commercialization of advanced molecular diagnostics systems, announced today it has received 510(k) clearance from the FDA for the Verigene® Staphylococcus Blood Culture Nucleic Acid Test (BC-S). The BC-S test expands Nanosphere's infectious disease test capabilities to include the rapid detection of bacteria that cause deadly bloodstream infections.
The Verigene BC-S test was submitted to the FDA as the first phase of a stepwise process to obtain clearance for a larger test panel which will be marketed as the Verigene BC-GP test. The test will be comprised of up to 16 bacterial/resistance marker targets, all on a single test cartridge. A second 510(k), needed to obtain clearance for the full BC-GP test panel, is currently under FDA review.* Last week, Nanosphere obtained CE-IVD Mark for regulatory approval of the full BC-GP test as an in vitro diagnostic in Europe.
"With the BC-S test, clinicians diagnosing patients suspected of deadly infections have a rapid, accurate molecular diagnostic tool which can differentiate two important disease-causing Staphylococcus bacteria, while simultaneously determining antibiotic resistance within the critical timeframe for making and adjusting initial treatment decisions," said Nanosphere CEO Bill Moffitt. "With this clearance we continue expansion of our product offering, enabling microbiologists to replace century-old methods with rapid, accurate molecular diagnostic tests," he added.
In a single automated test, the Verigene BC-S test provides detection of Staphylococcus aureus, Staphylococcus epidermidis, and the mecA gene. The mecA gene confers resistance to the antibiotic methicillin/oxacillin. Methicillin-resistant Staphylococcus aureus (MRSA) bacteremia is associated with a significantly higher mortality rate than methicillin-susceptible Staphylococcus aureus bacteremia, posing a substantial healthcare burden.1
The BC-S test provides species and resistance detection from two types of gram-positive blood culture bottles within two and a half hours, as compared with current microbiological culture methods, which can take up to 3 days. 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.2 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.3
The sample-to-result BC-S test automates the steps of bacterial nucleic acid extraction and target detection on the Verigene System. The ease-of-use and rapid turnaround time of the BC-S test allow hospitals of any size to benefit from the speed and accuracy of automated molecular testing.
About Bloodstream Infections
Septicemia is associated with more than 800,000 hospitalizations per year in the United States and is the most expensive cause of hospitalization.4 Septicemia 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.5
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.6 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 due to 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.
Wang FD, Chen YY, Chen TL, Liu CY. Risk factors and mortality in patients with nosocomial Staphylococcus aureus bacteremia. Am J Infect Control. 2008;36(2):118-22.
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.
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.
Elixhauser A, Friedman B, Stranges E. 2011. Septicemia in US Hospitals, 2009. HCUP Statistical Brief #122. Agency for Healthcare Research and Quality.
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.
- In the U.S., the Verigene BC-GP test is For Investigational Use Only.
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CONTACT: Public and investor relations: The Torrenzano Group Ed Orgon 212-681-1700 firstname.lastname@example.org Nanosphere, Inc. Zack Crowther (847) 400-9047 IDtesting@nanosphere.us
Source: Nanosphere, Inc. 2011 GlobeNewswire, Inc.