Nanosphere, a provider of advanced molecular diagnostics systems, has received US Food and Drug Administration (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, lik e the RV+ provides Influenza A, Influenza B, RSV A, and RSV B detection, and further subtypes Influenza A as H1, H3, or 2009 H1N1.
The RV+ test does not contain the recommendation to confirm all negative results with culture-based detection methods.
Nanosphere president and CEO William Moffitt said 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.
"Moreover, the RV+ test’s clearance enables molecular respiratory testing to begin moving into mainstream medicine," Moffitt said.
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.