Luminex respiratory panel cleared
This article was originally published in The Gray Sheet
Executive Summary
Toronto-based Luminex Molecular Diagnostics Jan. 3 obtains 510(k) clearance and launches its xTAG Respiratory Viral Panel, which detects 12 viruses and subtypes that are responsible for more than 85% of respiratory viral infections. xTAG RVP yields results in 10 hours and is the first test for detecting and differentiating influenza A subtypes H1 and H3, and for detecting human metapneumovirus. The test also detects influenza B; respiratory syncytial virus A and B; andenovirus; parainfluenza 1, 2 and 3; and rhinovirus