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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.

(Logo:  http://photos.prnewswire.com/prnh/20100104/LUMINEXLOGO)

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.

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