NEW YORK (GenomeWeb News) – Luminex said today that it has received clearance from the US Food and Drug Administration for its MagPix instrument and xTAG Gastrointestinal Pathogen Panel, or GPP.
The xTAG GPP assay is the first clinical assay to be cleared in the US for the MagPix instrument. It also is the first FDA-cleared test that can simultaneously detect 11 common viral, bacterial, and parasitic causes of infectious gastroenteritis from a single stool sample, Luminex said.
Specifically, xTag GPP tests for Campylobacter; Clostridium difficile Toxin A/B; Escherichia coli 0157; enterotoxigenic E. coli LT/ST; Shiga-like toxin-producing E. coli stx1/stx2; Salmonella; Shigella; Rotavirus A; Norovirus GI/GII; Giardia lamblia; and Cryptosporidium.
FDA in January cleared the xTAG GPP test for use on the previously approved Luminex 100/200 system.
The company said that MagPix is an easy-to-use and versatile multiplexing platform capable of performing qualitative and quantitative analysis of proteins and nucleic acids in a variety of sample matrices.
In addition, MagPix is compact, making it attractive to laboratories with limited bench space, and can perform up to 50 different tests in a single reaction volume, greatly reducing sample input, reagents, and labor while improving productivity, Luminex said.
While traditional GI testing technologies and methods can take several days to deliver a single result depending on the pathogen, xTAG GPP can deliver multiple results within five hours.