Medical instruments company Luminex Corporation (LMNX) Monday said it received U.S. FDA clearance of its MAGPIX instrument, with its xTAG Gastrointestinal Pathogen Panel or xTAG GPP.
The company said this is the first clinical assay to be cleared on MAGPIX and added that the xTAG GPP is the first U.S. IVD cleared test that can simultaneously detect 11 common viral, bacterial, and parasitic causes of infectious gastroenteritis from a single patient sample.
Commenting on the development, Patrick Balthrop, CEO of Luminex said, "Receiving FDA clearance of MAGPIX opens the door for clinical laboratories of all sizes to use xTAG GPP on this innovative instrument...By bringing a compact, cost-effective, easy-to-deploy multiplexing solution to the clinical market, MAGPIX makes molecular testing more accessible to all laboratories."
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