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Nanosphere Gets FDA OK for H1N1 Info in Package Insert for Assay

NEW YORK (GenomeWeb News) – Nanosphere today said that the US Food and Drug Administration has granted the firm 510(k) clearance to update the package insert for its Verigene Respiratory Virus Nucleic Acid Test to include reactivity with Influenza A in cultured clinical isolates containing 2009 H1N1 influenza virus.

The Northbrook, Ill.-based molecular diagnostics firm said that its tests had confirmed that the Verigene assay, which was cleared by FDA last month, correctly identifies Influenza A in cultured clinical isolates containing 2009 H1N1.

"Although the [assay] has been shown to detect the 2009 H1N1 influenza virus in cultured isolates, the performance characteristics of this device with patient specimens that are positive for the 2009 H1N1 influenza virus have not been established," Nanosphere said in a statement. It added that the assay can distinguish between Influenza A and B viruses, but it does not differentiate influenza subtypes.

Last month, the FDA cleared the Verigene Respiratory Virus Nucleic Acid Test to run on the firm's new Verigene SP system for the differential diagnosis of Influenza A, Influenza B, and RSV infections.

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