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


Tuesday, 15 Jan 2013 08:30am EST 

Luminex Corp announced 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 . 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 benefit to laboratories in terms of workflow and resource utilization. 

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1 Aug 2014