FDA has granted premarket notification (510(k)) clearance to the NxTag respiratory pathogen panel from Luminex Corp, Austin, Tex. The panel detects 20 clinically relevant viral and bacterial respiratory pathogens, including the atypical bacteria Chlamydophila pneumoniae and Mycoplasma pneumonia.
The respiratory panel enables laboratories to detect 20 respiratory pathogens simultaneously in a single closed-tube system, in a format that can be scaled to accommodate seasonal changes in demand. FDA clearance, which was received less than 90 days from submission, follows the CE mark received for the panel in October.
“We are excited to bring this next-generation respiratory pathogen panel to market,” says Homi Shamir, president and CEO of Luminex. “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.”
For Luminex, 2015 was a busy year. The company achieved multiple product development milestones, including FDA clearance of the Aries sample-to-answer molecular system. “These new products should position Luminex well for accelerating growth,” says Shamir.
Requiring only minutes of hands-on time with no upstream reagent preparation, the NxTag panel offers a simplified workflow that permits extracted samples to be added directly to preplated, lyophilized reagents. The sealed tubes are then ready for closed-tube amplification and subsequent detection using the Luminex Magpix instrument. A tube strip design affords laboratories the flexibility to manage variable sample demand by processing a single sample or as many as 96 samples per run, without requiring full batches or wasting consumables or reagents. Excluding time for extraction, turnaround time for processing 96 samples is just over 3 hours.
The respiratory pathogen panel is accompanied by Synct software that provides a comprehensive approach to data analysis and reporting, and enables the panel to be integrated into any laboratory’s workflow. Laboratories can select any of a number of targets to customize their testing panel.
For more information, visit Luminex.