Product News: Quidel Receives CE Mark for Sofia Legionella Fluorescent Immunoassay

08 Nov 2012

Quidel Corporation, a leading provider of diagnostic testing solutions and cellular-based virology assays, announced today that it has received the CE Mark for its Sofia Legionella FIA for use on the Sofia Analyzer for the rapid detection of Legionnaires' disease, also known as legionellosis.

Sofia is the brand name for Quidel's next generation, immunoassay system that was launched earlier this year. The Sofia Analyzer and Sofia Legionella FIA combine unique immunofluorescence chemistry, advanced lateral flow technology, and failure alert and fail-safe systems designed to ensure a reliable, objective, highly accurate, diagnostic result within ten minutes of application of the patient's specimen. The Sofia system was 510(k) cleared in October of 2011, and its first test, the Sofia Influenza A+B FIA, received Clinical Laboratory Improvement Amendments (CLIA) waiver by the U.S. FDA in April of 2012.

The CE Mark allows Quidel to launch its new Sofia Legionella FIA in Europe.

"We are extremely pleased to announce the CE Mark and impending launch of our fourth Sofia assay in Europe," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "The Sofia Legionella FIA will provide customers with an accurate, ten-minute solution for the diagnosis of Legionnaires' disease. Receiving the CE Mark is another milestone testifying to the promise of the aggressive development program we instituted nearly three years ago -- one achievement of which is the unique Sofia immunofluorescence platform and system."

The Sofia Legionella assay uses the Sofia Analyzer, an instrument that is designed to easily incorporate new analyte-specific algorithms -- an important feature as the Sofia menu of products expands. The other Sofia immunoassays presently for sale in Europe include FIAs for Influenza A+B, Strep A and RSV.