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FDA OKs Nanosphere, Inc.'s Test for Bloodstream Infections


6/29/2012 7:25:27 AM

Nanosphere, Inc., a leader in the development and commercialization of advanced molecular diagnostics systems, has received the US Food and Drug Administration (FDA) approval to market Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) on the automated sample-to-result Verigene System. The BC-GP test notably expands Nanosphere’s infectious disease test capabilities to include fast detection of bacteria that can cause deadly bloodstream infections, an increasingly recognized health threat. With a single automated test, the Verigene BC-GP test provides fast genus and species level detection for a broad panel of clinically significant gram-positive bacteria. The BC-GP test also detects several crucial markers for antimicrobial resistance, including the mecA, vanA, and vanB genes, which confer resistance to the antibiotics methicillin/oxacillin and vancomycin. Rapid detection of these antimicrobial resistance markers provides vital information for clinicians to determine the best treatment for bloodstream infections.


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