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Jul 20, 2011

Luminex’ xTAG FAST Assay for Respiratory Pathogens Granted 510(k) Approval

  • FDA granted 510(k) approval to Luminex’ xTAG Respiratory Viral Panel FAST (RVP FAST) test for respiratory infections. Designed for clinical and diagnostic laboratories, the xTAG RVP FAST assay can identify eight respiratory pathogens, in up to 96 patients, and provide results within hours. The pathogen panel includes: respiratory synctial virus, influenza A (nonspecific influenza A, H1 subtype and H3 subtype), influenza B, metapneumovirus, adenovirus, and entero-rhinovirus. xTAG RVP FAST is designed for use on the Luminex 100/200™ platform.

    xTAG RVP FAST is the latest addition to Luminex’s portfolio of molecular diagnostic tests for infectious diseases. The firm’s xTAG Gastrointestinal Pathogen Panel (GPP) received CE mark clearance in May. xTAG GPP simultaneously detects15 disease-causing gastrointestinal viral, bacterial, and parasitic infections, and generates results within five hours. The test is approved in Europe for the MAGPIX® and Luminex 100/200 systems. At the time of CE mark approval Luminex said it also intends to file for regulatory approval of the test in the U.S. and Canada.

    Luminex’ infectious disease assay portfolio also includes the MultiCode-RTx Herpes Simplex Virus 1&2 assay, which the firm claims is the first FDA-approved PCR-based qualitative test for detecting and typing HSV-1 and HSV-2. Its xTAG RVP assay, which was cleared by FDA in 2008, represented the first respiratory viral panel test for 12 viruses, including H1N1.

    Additional xTAG assays include the xTAG® Cystic Fibrosis Kit, and the xTAG CYP2D6 assay for detecting cytochrome P450 polymorphisms associated with drug metabolism.

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