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FDA Clears Three Additional Targets for Luminex Gastrointestinal Pathogen Panel

NEW YORK (GenomeWeb) – Luminex said after the close of the market on Monday that the US Food and Drug Administration has cleared three additional targets for its xTAG Gastrointestinal Pathogen Panel.

The new targets are Adenovirus 40/41, Entamoeba histolytica and Vibrio cholerae. FDA also cleared the assay for use with specimens in Cary-Blair medium, a common transport medium for collecting and preserving microbiological specimens.

FDA originally cleared xTAG GPP in January 2013 for the Luminex 100/200 system 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.

Luminex said the assay now tests for more than 90 percent of the causative pathogens of infectious gastroenteritis in one test, allowing clinicians to rapidly identify and treat the causative agent. Co-infections can also be more easily identified, the Austin, Texas-based company said.