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Quidel Receives FDA Clearance for Its Sofia Strep A Fluorescent Immunoassay

Quidel Corporation, a provider of rapid diagnostic testing solutions, cell-based virology assays and molecular diagnostic systems, announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its Sofia Strep A fluorescent immunoassay for use on the Sofia Analyzer for the rapid, objective detection of infections by Group A Streptococcus bacteria. These bacteria are the most common cause of bacterial pharyngitis and can also cause rheumatic fever and other potentially serious illnesses.

Sofia is the brand name for Quidel's next-generation, immunoassay system. The Sofia Analyzer and Sofia Strep A 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 five (5) minutes of application of the patient's specimen.

"We are confident that the Sofia Strep A FIA will provide customers with an easy-to-use, fast and accurate solution for the diagnosis of Strep A infections, and will create added utilization for the Sofia platform beyond current influenza testing," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "In the short-term, the clearance of the Sofia Strep A FIA provides us with another catalyst for increasing Sofia placements in the field, and before the onset of the upcoming respiratory disease season. Over the long-term, our premium product addresses a market that, relative to influenza, represents a higher volume opportunity with less seasonality and less volatility."

The 510(k) clearance allows Quidel to market and sell its new Sofia Strep A FIA in the United States. The Sofia Analyzer 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.

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