NEW YORK (GenomeWeb) – Luminex today said that it has submitted a 510(k) application to the US Food and Drug Administration for the NxTAG Respiratory Pathogen panel.
The company said it hopes to receive clearance to market the test before the end of the year.
Luminex said that the NxTAG panel enables laboratories to simultaneously detect 21 respiratory pathogens in a single closed-tube system in a format that scales to changes in throughput requirements. It requires only minutes of hands-on time and needs no upstream reagent preparation. Extracted samples are added directly to pre-plated lyophilized reagents, and the tubes are then sealed and ready to be used for closed-tube amplification and detection using Luminex Magpix platform.
Using the panel, laboratories can process as many as 96 samples per run without wasting consumables or reagents, the company said, adding that the total turnaround time for 96 samples, excluding extraction, is three hours. Additionally, the accompanying Synct software provides comprehensive data analysis and reporting, while allowing the NxTAG panel to integrate easily into any laboratory.
Luminex also recently submitted 510(k) applications to the FDA for its Aries MDx platform and HSV 1&2 Assay.