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
hcurrie@luminexcorp.com
Luminex Media Contact
Christine Valle, 512.219.8020
Sr. Manager, Global Marketing
cvalle@luminexcorp.com
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SOURCE Luminex Corporation