Nanosphere's respiratory virus subtyping test gets FDA go-ahead
This article was originally published in Clinica
Executive Summary
A test developed by Nanosphere to detect different types of respiratory viruses has received 510(k) clearance from the US FDA. The Verigene respiratory virus plus nucleic acid test (RV+) can identify influenza A and B, and respiratory syncytial virus (RSV) A and B. It also further classifies influenza A infections as H1, H3 or the 2009 H1N1 subtype. The test runs on the firm's Verigene system. The RV+ automates several testing steps including viral RNA extraction, multiplexed RT-PCR amplification and target detection, and only requires a single pipetting step. Northbrook, Illinois-based Nanosphere claims the product offers "the broadest respiratory panel available".