Luminex Receives FDA Clearance for First Comprehensive
Gastrointestinal Pathogen Infectious Disease Diagnostic in the
United States
AUSTIN, Texas, Jan. 15, 2013 /PRNewswire/ -- Luminex Corporation
(NASDAQ: LMNX) announced today that it has received FDA clearance
for its xTAG Gastrointestinal Pathogen Panel (GPP), the first
comprehensive molecular diagnostic assay that tests for greater
than 90% of bacterial, viral, and parasitic causes of infectious
gastroenteritis in a single assay. The xTAG GPP assay can be an
important clinical tool in the management of gastrointestinal
infections, and is now available in the
United States.
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Diarrheal disease strikes more than two billion times globally
each year and is a leading cause of child morbidity and mortality
worldwide(1). In the United
States alone, 99 million cases of GI infection occur
annually, leading to over 250,000 hospitalizations(2)
and 17,000 deaths(3), inflicting a significant toll on
the healthcare system. Diagnosis of some causes of infectious
gastroenteritis has traditionally required multiple tests across
the microbiology, virology, and molecular laboratories for which
results may not be available for several days.
As the first and most comprehensive multiplexed product of its
kind in the United States, xTAG
GPP is a nucleic acid-based amplification assay that simultaneously
tests for 11 of the most common gastroenteritis causing viruses,
bacteria, and parasites. The panel includes:
Campylobacter, Clostridium difficile Toxin A/B,
Escherichia coli O157, Enterotoxigenic E. coli (ETEC)
LT/ST, Shiga-like toxin producing E. coli (STEC) stx1/stx2,
Salmonella, Shigella, Rotavirus A, Norovirus GI/GII,
Giardia lamblia and Cryptosporidium.
Depending on the pathogen, currently available technologies and
methods can take several days to deliver a single result. xTAG GPP
is capable of delivering multiple results within 5 hours. The assay
is cleared on the widely available Luminex® 100/200™ system.
Additionally, simultaneous molecular testing on a single sample
within a single shift provides significant benefit to laboratories
in terms of workflow and resource utilization.
"In our experience, simultaneous testing for multiple GI
pathogens during routine clinical testing and outbreak
investigations enhances both our diagnostic capabilities and public
health laboratory efficiency," said Dr. Sanjib Bhattacharyya, Deputy Laboratory Director
at City of Milwaukee Health Department. "Routine use of xTAG GPP
will allow cost-effective, timely detection of multiple pathogens,
optimize use of laboratory resources, and elevate our understanding
of pathogen-associated diseases in gastroenteritis."
"CE IVD marked xTAG GPP has provided significant improvement to
laboratories and healthcare systems in Europe and other countries and we are pleased
to provide this important diagnostic to laboratories and patients
in the United States," said
Patrick J. Balthrop, president and
CEO of Luminex. "xTAG GPP has the potential to enable hospitals to
improve patient outcomes while saving money. Our continued
innovation is a reflection of the outstanding dedication of our
development team and our passion for creating breakthrough
solutions to improve health and advance science."
About xTAG GPP
The xTAG Gastrointestinal Pathogen Panel (GPP) is a multiplexed
nucleic acid test for the detection of multiple viral, parasitic,
and bacterial nucleic acids in human stool specimens from
individuals with signs and symptoms of infectious colitis or
gastroenteritis.
The detection and identification of specific gastrointestinal
microbial nucleic acid from individuals exhibiting signs and
symptoms of gastroenteritis aids in the diagnosis of
gastrointestinal infection and the investigation of acute
gastroenteritis outbreaks when used in conjunction with clinical
evaluation, laboratory findings, and epidemiological information.
xTAG GPP positive results are presumptive and must be
confirmed by FDA-cleared tests or other acceptable reference
methods.
For more information, please visit our website at
www.luminexcorp.com/gpp.
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 technology is 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/.
References:
1)
http://www.who.int/mediacentre/factsheets/fs330/en/index.html
2)
http://www.clevelandclinicmeded.com/medicalpubs/diseasemanagement/gastroenterology/acute-diarrhea/
3)
http://www.cdc.gov/media/releases/2012/p0314_gastroenteritis.html
Contact:
Investors:
Matt Scalo
Luminex Corporation
mscalo@luminexcorp.com
512.336.3587
Media:
Mimi Torrington
Luminex Corporation
mtorrington@luminexcorp.com
512.219.8020
Aaron DeLucia
Porter Novelli
aaron.delucia@porternovelli.com
512.241.2249
SOURCE Luminex Corporation