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FDA Clears Nanosphere Test for Gram-positive Bacteria

NEW YORK (GenomeWeb News) – Nanosphere today said that it has received de novo clearance from the US Food and Drug Administration to market its Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) on its Verigene System.

The test detects the genus and species for a broad panel of clinically significant gram-positive bacteria, as well as several markers of antimicrobial resistance, including the mecA, vanA, and vanB genes, which confer resistance to methicillin/oxacillin and vancomycin, Nanosphere said. It added that the test can identify bacterial and antimicrobial resistance genes from gram-positive blood culture bottles within two-and-a-half hours, compared to the two to three days required by current microbiological methods.

The sample-to-result BC-GP test automates bacterial DNA extraction and target detection on the Verigene system.

"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," Nanosphere CEO William Moffitt said in a statement.

The Northbrook, Ill.-based company added that it is developing a test for gram-negative blood cultures that will detect genus, species, and resistance on an automated platform. It also plans to submit a test for C. difficile and a panel of enteric bacterial and viral pathogens for FDA clearance this year.

Shares of Nanosphere closed up 21 percent at $2.32 in Wednesday trade on the Nasdaq.