FDA approves new gram-positive blood culture test

Source：Nanosphere, Inc. Release Date：2012-07-05 604

Medical Equipment

FDA grants Nanosphere de novo petition to market gram-positive blood culture test (BC-GP)

NORTHBROOK, IL -- Nanosphere, Inc. have announced that the US Food and Drug Administration (FDA) has granted a de novo petition permitting marketing of its gram-positive blood culture nucleic acid test (BC-GP) on the automated sample-to-result Verigene? System.

The Verigene BC-GP test is able to detect genus and species for a broad panel of gram-positive bacteria in a single automated test. It is also able to detect markers for antimicrobial resistance, such as the mecA, vanA, and vanB genes, which confer resistance to the antibiotics methicillin/oxacillin and vancomycin.

“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 can identify bacteria and antimicrobial resistance genes from gram-positive blood culture bottles within two and a half hours, compared to current microbiological methods which may 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.

Nanosphere is also currently developing a test for gram-negative blood cultures that will provide genus, species, and resistance detection on the same automated platform.

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