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FDA Clears Luminex's Gastrointestinal Pathogen Assay

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has cleared Luminex's xTAG Gastrointestinal Pathogen Panel for marketing in the US, Luminex announced today.

The assay is cleared to run on the Luminex 100/200 system, and Luminex said that it is "the first comprehensive molecular diagnostic assay that tests more than 90 percent of bacterial, viral, and parasitic causes of infectious gastroenteritis in a single assay."

A nucleic acid amplification assay, xTAG GPP simultaneously tests for 11 common gastroenteritis-causing viruses, bacteria, and parasites, including Campylobacter; Clostridium difficile Toxin A/B; Escherichia coli 0157; 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.

Assay results are presumptive and must be confirmed by FDA-cleared tests or other acceptable methods, Luminex said.

Worldwide, there are more than 2 billion cases of diarrheal diseases annually, and some instances of infectious gastroenteritis require multiple testing across microbiology, virology, and molecular laboratories. While such tests can take days for results, the xTAG GPP assay can yield results in five hours, Luminex said.

"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," Sanjib Bhattacharyya, deputy laboratory director at the City of Milwaukee Health Department, said in a statement. "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."