Luminex's NxTAG Respiratory Pathogen Panel obtains FDA clearance

Luminex Corporation (NASDAQ: LMNX) today announced that it has received FDA clearance for its NxTAG® Respiratory Pathogen Panel that detects 20 clinically relevant viral and bacterial respiratory pathogens, including the atypical bacteria Chlamydophila pneumoniae and Mycoplasma pneumonia. The panel is the only respiratory assay that enables laboratories to easily and simultaneously detect 20 respiratory pathogens in a single closed tube system in a format that scales to accommodate changes in throughput needed to respond to seasonal changes in demand, especially during flu season. 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," said 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. With advantages such as minimal hands-on time, fast time to results, and target masking for panel customization, the NxTAG Respiratory Pathogen Panel offers clear advantages when compared with other respiratory panels on the market. In conclusion, 2015 has been a busy year with multiple product development milestones achieved, of which the FDA clearance of NxTAG Respiratory Pathogen Panel follows closely the FDA clearance of the ARIES sample to answer molecular system. These new products should position Luminex well for accelerating growth."

The NxTAG Respiratory Pathogen Panel requires only minutes of hands-on time, with no upstream reagent preparation. A simplified workflow allows extracted samples to be 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. 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. Any of a number of targets can be selected by laboratories to customize their testing panel.

Why Test for Respiratory Pathogens?

Many commonly encountered respiratory pathogens (viral and bacterial) have similar clinical presentation, making diagnosis based on symptoms alone very difficult. Influenza viruses commonly cause respiratory illness, but many other pathogens may cause significant impact on patient health as well. Respiratory syncytial virus (RSV), as one example, is the most common cause of severe respiratory illness in young children, as well as a leading cause of death from respiratory illness in those aged 65 years and older.

A clinician needs to accurately detect the respiratory pathogen causing illness in the patient in order to effectively prescribe treatment and control the spread of infection. Laboratories need respiratory assays that can rapidly and efficiently detect these relevant pathogens with minimal hands-on time and no post-PCR handling to meet laboratory, physician, and patient needs.