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2nd July 2012  Content supplied by: Nanosphere Inc.

Gram+ve Blood Culture Test also Detects Antimicrobial Resistance

The US Food and Drug Administration has granted a de novo petition permitting Nanosphere, Inc. to market its Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) on the automated sample-to-result VerigeneĀ® 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.

"With the BC-GP test, patients suspected of deadly infections can now get a first-ever diagnostic tool for detecting disease-causing bacteria while simultaneously determining antibiotic resistance within the critical timeframe for making and adjusting initial treatment,' said William Moffitt, Nanosphere's Chief Executive Officer.

The 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.

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 fast 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 are part of a comprehensive infectious disease test menu, including the multiplexed Verigene RV+ respiratory virus test cleared by the FDA in 2011, as well as tests for C. difficile and a panel of enteric bacterial and viral pathogens that Nanosphere plans to submit for FDA clearance in 2012.


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Date Published: 2nd July 2012

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