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May 5, 2011

Luminex’ xTAG Gastrointestinal Pathogen Panel Gains CE Mark

  • Luminex xTAG Gastrointestinal Pathogen Panel (GPP) has been granted a CE mark in the European Union. Based on Luminex’ multiplexing xMAP® microsphere platform, the PCR-based molecular test is designed to simultaneously detect and identify 15 parasitic, bacterial, and viral pathogens from a single stool sample and generate results within five hours. The xTAG GPP assay is CE-marked for the Magpix® and Lumix® 100/200™ systems. Luminex says it plans to file for regulatory approval of the panel in the U.S. and Canada.

    The xTAG GPP assay is the latest in a family of xTAG tests from Luminex. The firm’s xTAG Cystic Fibrosis (CFTR) v2 series of assays has also been granted a CE mark in Europe and is IVD-certified in the U.S. xTAG Cystic Fibrosis comprises a family of assays designed to test either for just the 23 CFTR mutations recommended by the ACMG/ACOG, the 23 recommended mutations plus an additional 16 mutations (CFTR 39 kit v2), or an additional 37 mutations (CFTR 60 kit v2) that represent the most common CFTR mutations worldwide and in North America.

    Also CE-marked and IVD certified are the xTAG RVPv1 and xTAG RVP FAST assays for the simultaneous detection and identification of multiple respiratory virus nucleic acids in nasopharyngeal swabs. The similarly certified xTAG CYP2D6 assay has been developed to detect polymorphisms associated with drug metabolism to help determine appropriate use of therapeutics that are metabolized by the CYP2D6 gene product.


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