Quidel Receives CE Mark for Its Sofia Fluorescent Immunoassay Analyzer and Influenza A+B FIA Test

Quidel Corporation QDEL announced today that it has received the CE Mark for its Sofia® Fluorescent Immunoassay Analyzer and for its Sofia® Influenza A+B Fluorescent Immunoassay. Sofia is the brand name for Quidel's next generation, immunoassay system. The Sofia Analyzer and Sofia Influenza A+B FIA combine unique fluorescent chemistry, advanced lateral flow technology, and failure alert and fail safe systems to ensure a reliable, objective, rapid, and highly accurate diagnostic result. The Sofia Analyzer is light weight, has a small footprint, and has operational flexibility making it easy to use in small and large laboratories. It also provides a permanent test result record and can be readily networked for electronic transmission of test results. The Sofia Influenza A+B FIA is the first of several forthcoming diagnostic assays for infectious disease and other disorders that will incorporate Sofia-related immunochemistry and will use the Sofia Analyzer. The CE mark allows Quidel to launch the Sofia Immunoassay Analyzer and Sofia Influenza A+B FIA in advance of the upcoming influenza season in Europe and in other locations outside the United States. The product is currently not for sale in the U.S.