FDA Clearance for Luminex xTAG® Gastrointestinal Pathogen Panel
Luminex Corporation 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.
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.
'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.'