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FDA Clears Luminex's xTag Respiratory Viral Panel Fast Test

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Luminex said after the close of the market on Tuesday that the US Food and Drug Administration has given 510(k) clearance for its xTag Respiratory Viral Panel Fast.

The panel includes respiratory syncytial virus; influenza A; non-specific influenza A; H1 subtype; H3 subtype; influenza B; metapneumovirus; adenovirus; and entero-rhinovirus.

The availability of the test, Luminex said, will provide diagnostic laboratories testing options for a frontline assay that targets eight essential respiratory pathogens and delivers up to 96 patient results in a few hours.

The xTag RVP Fast panel runs on Luminex's 100/200 platform and will be commercially available from Abbott Molecular Diagnostics and Fisher Healthcare, Luminex's distribution partners.

Other molecular diagnostics from Luminex for infectious disease include the xTag RVP for respiratory viral panel testing of 12 viruses such as H1N1; the xTag Gastrointestinal Pathogen Panel; and the MultiCode-RTx Herpes Simplex Virus 1&2, the first FDA-approved PCR-based qualitative test for detecting and typing HSV-1 and HSV-2.