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www.fdanews.com/articles/170687-luminex-announces-launch-of-respiratory-pathogen-panel-for-research-use-only

Luminex Announces Launch of Respiratory Pathogen Panel for Research Use Only

April 8, 2015

Luminex launched its NxTAG Respiratory Pathogen Panel for Research Use Only. It is the first respiratory assay test capable of simultaneously detecting 22 respiratory pathogens in a closed tube system and accommodating the higher throughput required to react to seasonal changes in demand, the Austin, Tex., devicemaker claims.

The assay test takes only a few minutes and does not require upstream reagent preparation, with extracted samples added directly to pre-plated, lyophilized reagents. Afterward, tubes are sealed and prepared for closed tube amplification and ensuing pathogen detection using Luminex’s MAGPIX system.

The tube strip design allows laboratories to effectively manage sample demand by processing a single sample or up to 96 samples per run without wasting consumables or reagents. Excluding extraction, the assay test turnaround time is estimated at three hours for 96 samples, the company says.

Clinical trials are underway and Luminex is pursuing FDA, CE Mark and Health Canada approval, a spokeswoman told Device Daily Wednesday.

Viral and bacterial respiratory pathogens feature comparable symptoms, making diagnosis more difficult. Respiratory syncytial virus is one of the most common causes of severe respiratory illness in young children, as well as being the leading cause of death from respiratory illness in people 65 and older. — Jason Scott