American Food and Drug Administration (FDA) marketing approval has been granted for a diagnostic panel that incorporates tests for 21 clinically-relevant viral and bacterial respiratory pathogens into a single closed microtiter plate well.

The wide range of the Luminex Corporation (Austin, TX, USA) NxTAG Respiratory Pathogen Panel also includes such atypical bacteria as Chlamydophila pneumoniae, Mycoplasma pneumoniae, and Legionella pneumophila.

The NxTAG panel was designed for use with the Luminex MAGPIX instrument, which operates with fluorescent markers and magnetic microbeads. Each sample to be tested requires only minutes of hands-on time with no upstream reagent preparation. Simplified workflow allows extracted samples to be added directly to pre-plated, lyophilized reagents. The wells are then sealed and ready for closed tube amplification and subsequent detection using the Luminex MAGPIX instrument. 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, or the need to have full batches. Total turnaround time is just over three hours for 96 samples.

"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."

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