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Nanosphere Receives 510(k) FDA Clearance To Update Package Insert For Respiratory Virus Assay

To include reactivity with influenza A in cultured clinical isolates containing 2009 H1N1 influenza virus

Nanosphere 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 (RVNATSP). It is 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 said that although RVNATSP 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. The RVNATSP can distinguish between Influenza A and B viruses, but it does not differentiate influenza subtypes.

Reportedly, RVNATSP incorporates viral RNA extraction and isolation, RT-PCR amplification, and multiplexed detection in a fully automated system that requires only a single pipetting step. The automated Verigene SP System provides sample-to-result molecular diagnostics capabilities in a multiplexed, random-access, modular system utilising the same imaging technology as the first generation Verigene. It allows for complementary or stand alone integration into both molecular and microbiology laboratories.

William Moffitt, president and CEO of Nanosphere, 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. Nanosphere’s Respiratory Virus Assay run on the Verigene SP platform provides clinicians with a ‘sample-to-result’ system that combines the benefits of high sensitivity and specificity with ease of use and rapid turn-around time.”