Luminex Corporation Submits 510(k) Application for the NxTAG® Respiratory Pathogen Panel
AUSTIN, Texas, Aug. 26, 2015 /PRNewswire/ -- Luminex Corporation (NASDAQ: LMNX) today announced that it has submitted a 510(k) application to the FDA for the company's NxTAG® Respiratory Pathogen Panel. This panel is the only respiratory assay that will easily enable laboratories to simultaneously detect 21 respiratory pathogens in a single closed tube system in a format that scales to changes in throughput requirements and responds to seasonal changes in demand.
"With the FDA submission of the NxTAG Respiratory Pathogen Panel, we are demonstrating our continued focus on delivering solutions that address our customers' productivity needs," said Homi Shamir, President and CEO of Luminex. "Luminex is a leader in multiplexed solutions, and the next generation NxTAG Respiratory Pathogen Panel delivers expanded panel coverage and a simple closed tube workflow, combined with the throughput and quality of results established by the xTAG Respiratory Viral Panel. We hope to receive FDA clearance and CE-IVD marking before the end of the year."
Dr. Yi-Wei Tang, Chief of the Clinical Microbiology Service at the Memorial Sloan-Kettering Cancer Center and a Professor of Pathology and Laboratory Medicine at the Weill Medical College of Cornell University in New York City, has evaluated the NxTAG Respiratory Pathogen Panel (RUO) product and stated, "because of its high and scalable throughput capabilities, the NxTAG Respiratory Pathogen Panel is a useful platform when high throughput testing is needed during burdensome influenza seasons and pandemics."
The NxTAG Respiratory Pathogen Panel requires only minutes of hands-on time with no upstream reagent preparation. Extracted samples are 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, and the 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.
To learn more or request a demo, visit: http://www.luminexcorp.com/nxtag.
About Luminex Corporation
Luminex is committed to applying its passion for innovation toward creating breakthrough solutions to improve health and advance science. The company is transforming global healthcare and life-science research through the development, manufacturing and marketing of proprietary instruments and assays utilizing xMAP® open-architecture multi-analyte platform, MultiCode® real-time polymerase chain reaction (PCR), and multiplex PCR-based technologies, that deliver cost-effective rapid results to clinicians and researchers. Luminex's technologies are commercially available worldwide and in use in leading clinical laboratories, as well as major pharmaceutical, diagnostic, biotechnology and life-science companies. Luminex is meeting the needs of customers in markets as diverse as clinical diagnostics, pharmaceutical drug discovery, biomedical research including genomic and proteomic research, personalized medicine, biodefense research and food safety. For further information on Luminex Corporation and the latest advances in multiplexing using award winning technology, please visit http://www.luminexcorp.com/.
Statements made in this release that express Luminex's or management's intentions, plans, beliefs, expectations or predictions of future events are forward-looking statements. Forward- looking statements in this release include statements regarding the development and testing progress of our pipeline products, including ARIES and related assays, and the regulatory approvals thereof. The words "believe", "expect", "intend", "anticipates", "confident", "will", "could", "should", and similar expressions are intended to further identify such forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. It is important to note that the Company's actual results or performance could differ materially from those anticipated in such forward-looking statements. Factors that could cause Luminex's actual results or performance to differ materially include risks and uncertainties relating to, among others, our ability to launch products on time, the timing of regulatory approvals, the outcome of clinical trials as well as the risks discussed under the heading "Risk Factors" in Luminex's Reports on Forms 10-K and 10-Q, as filed with the Securities and Exchange Commission. The forward looking statements contained herein represent the judgment of Luminex as of the date of this press release, and Luminex expressly disclaims any intent, obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in Luminex's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
Contacts:
Luminex Investor Contact
Harriss Currie, 512.219.8020
Sr. Vice President of Finance and CFO
[email protected]
Luminex Media Contact
Christine Valle, 512.219.8020
Sr. Manager, Global Marketing
[email protected]
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SOURCE Luminex Corporation
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