Nanosphere, Inc. (NSPH) announced it has received 510(k) clearance from the FDA to update its package insert for its Verigene Respiratory Virus Nucleic Acid Test on Verigene SP System, or RVNATSP, to include reactivity with Influenza A in cultured clinical isolates containing 2009 H1N1 influenza virus.
Nanosphere confirmed through analytical reactivity testing that their RVNATSP assay correctly identifies Influenza A in cultured clinical isolates containing 2009 H1N1. The RVNATSP assay was cleared by the FDA in October 2009, for the differential diagnosis of Influenza A, Influenza B, and RSV infections.
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