FDA clears Nanosphere's RV+ test for detection of respiratory viruses

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.


 Nanosphere, Inc



The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News-Medical.Net.
Post a new comment
You might also like... ×
Researchers shed new light on MS relapse during upper respiratory infections