Molecular diagnostics system provider Nanosphere, Inc. (NSPH: Quote) announced that U.S. Food and Drug Administration has granted a de novo petition permitting marketing of its Gram-Positive Blood Culture Nucleic Acid Test or BC-GP on the automated sample-to-result Verigene System. The test will help fast detection of bacteria in bloodstream infections.
A single test using Verigene BC-GP would provide fast genus and species level detection for a broad panel of clinically significant gram-positive bacteria. The BC-GP test can detect markers such as mecA, vanA, and vanB genes, which confer resistance to the antibiotics methicillin/oxacillin and vancomycin.
William Moffitt, chief executive officer, said BC-GP test provides identification of bacteria and antimicrobial 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 two to three days.
Nanosphere said it plans to submit for FDA clearance in 2012.
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by RTT Staff Writer
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