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Nanosphere Gains 510(k) Clearance for Respiratory Virus Subtyping Panel

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Nanosphere said today that it has been granted 510(k) clearance from the US Food and Drug Administration for its Verigene Respiratory Virus Plus Nucleic Acid Test, which runs on the Verigene system.

Nanosphere said that the RV+ test detects influenza A and B and respiratory syncytial virus A and B, and further subtypes flu A as H1, H3, or 2009 H1N1.

The company said that the test automates viral RNA extraction, multiplexed RT-PCR amplification, and target detection on the Verigene system and requires a single pipetting step.

Last year, the FDA categorized Nanosphere's previous respiratory assay for the Verigene system as "moderate complexity" under the Clinical Laboratory Improvement Amendments of 1988.

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