Luminex Corporation Receives U.S. FDA Clearance for MAGPIX® Instrument with
Novel xTAG® Gastrointestinal Pathogen Panel
Innovative multiplexing instrument for clinical laboratories with simultaneous
testing for greater than 90% of bacterial, viral, and parasitic causes of
infectious gastroenteritis in a single molecular test now available
AUSTIN, Texas, April 15, 2013
AUSTIN, Texas, April 15, 2013 /PRNewswire/ -- Luminex Corporation (NASDAQ:
LMNX) today announced it has received U.S. FDA clearance of its MAGPIX
instrument, with its xTAG Gastrointestinal Pathogen Panel (xTAG GPP). This is
the first clinical assay to be cleared on MAGPIX. xTAG GPP is the first U.S.
IVD cleared test that can simultaneously detect 11 common viral, bacterial,
and parasitic causes of infectious gastroenteritis from a single patient
"Receiving FDA clearance of MAGPIX opens the door for clinical laboratories of
all sizes to use xTAG GPP on this innovative instrument," said Patrick J.
Balthrop, president and chief executive officer of Luminex. "By bringing a
compact, cost-effective, easy-to-deploy multiplexing solution to the clinical
market, MAGPIX makes molecular testing more accessible to all laboratories."
Based on Luminex's xMAP® Technology, the easy-to-use MAGPIX instrument is a
versatile multiplexing platform capable of performing qualitative and
quantitative analysis of proteins and nucleic acids in a variety of sample
matrices. MAGPIX is compact making it attractive to laboratories with limited
bench space. This affordable system can perform up to 50 different tests in a
single reaction volume, greatly reducing sample input, reagents, and labor
while improving productivity.
Traditional GI testing technologies and methods can take several days to
deliver a single result depending on the pathogen. xTAG GPP is capable of
delivering multiple results within five hours. Simultaneous molecular testing
on a single sample within a single shift provides significant benefits to
laboratories in terms of workflow and resource utilization.
"Tests such as the xTAG GPP that can detect viruses, bacteria, and parasites
from one sample at the same time can help clinicians more quickly identify and
treat what's causing gastroenteritis," said Alberto Gutierrez, Ph.D., director
of the Office of In Vitro Diagnostics and Radiology at the FDA's Center for
Devices and Radiological Health in an FDA press release when xTAG GPP was
first approved by the Agency. "The test could also allow clinicians and public
health professionals to more quickly identify and investigate the source of
potential gastroenteritis outbreaks."
Luminex will be featuring xTAG GPP and demonstrating the MAGPIX instrument at
the Clinical Virology Symposium (CVS), April 28–May 1 in Daytona Beach, FL,
Booth #237. For more information on MAGPIX or xTAG GPP, please visit our
website at www.luminexcorp.com.
Infectious gastroenteritis is an inflammation of the stomach and intestines
caused by certain viruses, bacteria, or parasites. Common symptoms include
vomiting and diarrhea, which can be more severe in infants, the elderly, and
people with suppressed immune systems. Gastroenteritis can be spread easily
through person-to-person contact and contaminated food, water, and surfaces.
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 Gastrointestinal (GI) infection occur
annually, leading to more than 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.
For more information visit www.gastroenteritis.com
MAGPIX is easy to install out of the box and weighs less than 40 lbs.
(approximately 18 kg), making it simple and affordable to ship and deploy
anywhere in the world. MAGPIX features an innovative and robust detection
mechanism that uses high performing light-emitting diodes (LEDs) and a CCD
imaging system, with state-of-the-art software.
About xTAG GPP
xTAG Gastrointestinal Pathogen Panel 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. xTAG GPP detects the following potential causes of
Clostridium difficile (C. difficile) toxin A/B
Escherichia coli (E. coli) O157
Enterotoxigenic E. coli (ETEC) LT/ST
Shiga‐like Toxin producing E. coli (STEC) stx 1/stx 2
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. The assay is cleared on Luminex's MAGPIX
instrument as well as on the Luminex® 100/200™ system.
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
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