Tuesday, Nanosphere, Inc. (NSPH), a provider of advanced molecular diagnostics systems, announced it has received 510(k) pre-market 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.
The company indicated that the RVNATSP can distinguish between Influenza A and B viruses, but it does not differentiate influenza subtypes. The performance characteristics of this device with patient specimens that are positive for the 2009 H1N1 influenza virus have not been established.
William Moffitt, Nanosphere's president and chief executive officer said,"This FDA clearance provides added assurance to our customers that our Verigene Respiratory Virus Assay correctly identifies Influenza A in cultured clinical isolates containing 2009 H1N1 influenza virus."
NSPH is currently being traded at $6.13 down $0.26 or 4.07% on the Nasdaq.
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