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FDA Clearance for Luminex Corporation's NxTAG® Respiratory Pathogen Panel
Luminex Corporation (NASDAQ: LMNX) has received FDA clearance for its NxTAG® Respiratory Pathogen Panel.
Luminex Corporation (NASDAQ: LMNX) has received FDA clearance for its NxTAG® Respiratory Pathogen Panel.
According to the press release:
[The panel] detects 20 clinically relevant viral and bacterial respiratory pathogens, including the atypical bacteriaChlamydophila 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.”
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