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/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 sample.
"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.
About Gastroenteritis 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.
About MAGPIX 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 gastroenteritis:
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/.