Nanosphere, Inc. (NSPH) Tuesday said the FDA approved its diagnostic test for detection of two variations of Staphylococcus bacteria and resistance, enabling appropriate antibiotic treatment. Shares of the Northbrook, Illinois-headquartered company surged over 20 percent on the news.
The Verigene Staphylococcus Blood Culture Nucleic Acid Test or 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. Studies reveal a 7.6 percent decrease in survival rate for each hour that therapy is delayed. The company also cited hospital cost savings of up to $21,000 per patient from another study.
CEO Bill Moffitt said," With this clearance we continue expansion of our product offering, enabling microbiologists to replace century-old methods with rapid, accurate molecular diagnostic tests."
In a single automated test, the Verigene BC-S test provides detection of Staphylococcus aureus, Staphylococcus epidermidis, and the mecA gene which confers resistance to the antibiotic methicillin/oxacillin. Methicillin-resistant Staphylococcus aureus or MRSA bacteremia is associated with a significantly higher mortality rate than methicillin-susceptible Staphylococcus aureus bacteremia.
The entry of a bacterium or a fungus into the bloodstream causes an inflammatory immune response. The condition known as Septicemia is associated with more than 800,000 hospitalizations per year in the United States. Bloodstream infections with gram-positive bacteria are often complicated by antimicrobial resistance. Rapid identification of both organism and resistance is essential to implementing efficient and appropriate therapy.
The Verigene BC-S test was submitted to the FDA as the first phase of a process to obtain clearance for a larger test panel, which would comprise up to 16 bacterial/resistance marker targets, all on a single test cartridge. Another 510(k) clearance for the full panel is under FDA review. Last week, Nanosphere obtained CE-IVD Mark for regulatory approval of the full test as an in vitro diagnostic in Europe.
NSPH last traded at $1.53, up $0.26 or 20.47%, on a volume of 1.1 million shares, on the Nasdaq. Over the past year, the stock traded in a range of $0.89 - $5.54, with three-month average volume of 0.3 million shares.
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