Luminex Corporation has submitted a a 510(k) application to the FDA for its NxTAG respiratory pathogen panel, according to PharmaBiz.
“With the FDA submission of the NxTAG respiratory pathogen panel, we are demonstrating our continued focus on delivering solutions that address our customers’ productivity needs,” said Homi Shamir, president and CEO of Luminex. “Luminex is a leader in multiplexed solutions, and the next generation NxTAG respiratory pathogen panel delivers expanded panel coverage and a simple closed tube workflow, combined with the throughput and quality of results established by the xTAG Respiratory Viral Panel. We hope to receive FDA clearance and CE-IVD marking before the end of the year.”
Dr. Yi-Wei Tang, chief of the clinical microbiology service at the Memorial Sloan-Kettering Cancer Center and a Professor of Pathology and Laboratory Medicine at the Weill Medical College of Cornell University in New York City, has evaluated the NxTAG respiratory pathogen panel (RUO) product and stated, “Because of its high and scalable throughput capabilities, the NxTAG Respiratory Pathogen Panel is a useful platform when high throughput testing is needed during burdensome influenza seasons and pandemics.”