Nanosphere, Inc., a leader in the development and commercialization of advanced molecular diagnostics systems, announced today FDA 510(k) clearance for the Verigene® Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene® System.
The RV+ test expands Nanosphere's existing test capabilities for the detection of respiratory viruses. In a single test, the RV+ provides Influenza A, Influenza B, RSV A, and RSV B detection, and further subtypes Influenza A as H1, H3, or 2009 H1N1.
"This timely clearance of RV+ will let Nanosphere offer customers the broadest respiratory virus panel available in the market on a sample-to-result platform," said William Moffitt, Nanosphere's president and chief executive officer. "Moreover, the RV+ test's clearance enables molecular respiratory testing to begin moving into mainstream medicine."
The RV+ automates the steps of viral RNA extraction, multiplexed RT-PCR amplification, and target detection on the Verigene® System and requires only a single pipetting step. Operationally similar, Nanosphere's existing respiratory assay cleared on the same Verigene® System received a CLIA categorization of "moderate complexity."
The RV+ test does not contain the recommendation to confirm all negative results with culture-based detection methods. Additionally, the random access, rapid turn-around time, and ease-of-use attributes allow any hospital to benefit from the high sensitivity and specificity of molecular testing without sacrificing the convenience and accessibility of rapid testing.