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Luminex seeks FDA approval for NxTAG Respiratory Pathogen Panel

Luminex is seeking approval from the US Food and Drug Administration (FDA) for its NxTAG Respiratory Pathogen Panel.

The company has submitted a 510(k) application to the FDA for the panel, which is claimed to be the only respiratory assay that will help laboratories to simultaneously detect 21 respiratory pathogens in a single closed tube system.

Luminex president and CEO Homi Shamir said: "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.

"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."

According to the firm, the NxTAG panel needs only minutes of hands-on time with no upstream reagent preparation and extracted samples are added directly to pre-plated and lyophilized reagents.

The tubes will be then sealed to undergo amplification and subsequent detection by using the Luminex Magpix instrument.

The tube strip design enables laboratories 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.

In addition, the accompanying Synct Software is said to offer a comprehensive approach to data analysis and reporting, allowing the panel to integrate easily into any laboratory.