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

Quidel Corporation, a leading provider of rapid diagnostic testing solutions and cell-based virology assays, announced today that it has received the CE Mark for its Sofia(R) Fluorescent Immunoassay Analyzer and for its Sofia(R) Influenza A+B Fluorescent Immunoassay (FIA).

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.

"Obtaining a CE mark for our Sofia Analyzer and Influenza Assay ahead of the next flu season is a significant accomplishment," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "We are very delighted with the milestones we have achieved with respect to our new product pipeline, and specifically with our next-generation immunoassay platform."

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