Luminex Corporation has submitted a 510(k) application to the FDA for the company's NxTAG respiratory pathogen panel. This panel is the only respiratory assay that will easily enable laboratories to simultaneously detect 21 respiratory pathogens in a single closed tube system in a format that scales to changes in throughput requirements and responds to seasonal changes in demand.
"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."
The NxTAG respiratory pathogen panel requires only minutes of hands-on time with no upstream reagent preparation. Extracted samples are added directly to pre-plated, lyophilized reagents. The tubes are then sealed and ready for closed tube amplification and subsequent detection using the Luminex MAGPIX instrument. The innovative tube strip design offers laboratories the flexibility to manage variable sample demand by processing a single sample or up to as many as 96 samples per run, without wasting consumables or reagents, and the total turnaround time is only about three hours for 96 samples (excluding extraction). In addition, the accompanying SYNCT Software provides a comprehensive approach to data analysis and reporting, and enables the NxTAG Respiratory Pathogen Panel to integrate easily into any laboratory.
Luminex is committed to applying its passion for innovation toward creating breakthrough solutions to improve health and advance science.