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Luminex Receives FDA Clearance for NxTag Respiratory Pathogen Panel

NEW YORK (GenomeWeb) – Luminex said today that its NxTag Respiratory Pathogen Panel has received US Food and Drug Administration clearance. 

The panel received clearance less than 90 days from submission, following the CE Mark that Luminex received for the panel in October.

Many commonly encountered respiratory pathogens are difficult to diagnose based on symptoms alone since they have similar clinical presentation. This presents a problem since clinicians need to be able to accurately identify an illness in a patient in order to effectively prescribe treatment and control the spread of infection.

NxTag RPP enables laboratories to easily and simultaneously detect 20 respiratory pathogens in a single closed-tube system, including atypical bacteria Chlamydophila pneumoniae and Mycoplasma pneumonia. The panel requires only minutes of hands-on time with no upstream reagent preparation, and has a simplified workflow that allows extracted samples to be added directly to pre-plated, lyophilized reagents. The tubes are then sealed for amplification and detection using the Luminex Magpix platform. 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. Total turnaround time is about three hours for 96 samples, excluding extraction.

In addition, the panel comes with Synct software that provides a comprehensive approach to data analysis and reporting, and enables the respiratory pathogen panel to integrate easily into any laboratory.

"The NxTag Respiratory Pathogen Panel incorporates extensive user feedback, delivers expanded panel coverage, features a simple closed tube workflow, and is combined with the throughput and quality of results established by the xTag Respiratory Viral Panel," Luminex President and CEO Homi Shamir said in a statement.

Luminex has achieved multiple product development milestones in 2015, including FDA clearance of the Aries sample-to-answer molecular system. "These new products should position Luminex well for accelerating growth," Shamir said.