Luminex Receives FDA Clearance for First Comprehensive Gastrointestinal
Pathogen Infectious Disease Diagnostic in the United States
xTAG® Gastrointestinal Pathogen Panel (GPP) simultaneously tests for greater
than 90% of bacterial, viral, and parasitic causes of infectious
gastroenteritis in a single molecular test.
AUSTIN, Texas, Jan. 15, 2013
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.
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
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/.
SOURCE Luminex Corporation
Press spacebar to pause and continue. Press esc to stop.