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Luminex Receives FDA Clearance For First Comprehensive Gastrointestinal Pathogen Infectious Disease Diagnostic In The United States

"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

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

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