Leading diagnostic test solutions provider Quidel Corporation (QDEL) recently won the European CE Mark for its Sofia Streptococcus A (“Strep A”) test for use with its Sofia Analyzer. The product is currently not available for sale in the U.S.
The CE Mark follows the U.S. regulatory clearance of the California-based company’s Sofia Analyzer and Sofia Influenza A+B test in October 2011. Both Sofia Strep A and Sofia Influenza A+B tests uses the Sofia Analyzer.
The Sofia Strep A and Sofia Analyzer integrates unique fluorescent chemistry, advanced lateral flow technology as well as failure alert and fail-safe systems to ensure a reliable, fast and highly accurate diagnostic results.
Quidel noted that Sofia Strep A is the second diagnostic test (after Sofia Influenza A+B) that incorporate Sofia-related immunochemistry. The company is currently developing several tests for infectious diseases and other disorders for use with Sofia Analyzer.
The CE Mark represents an important milestone for Quidel as it will enable the company to roll out the Sofia Strep A in advance of the respiratory disease season in Europe and in other regions outside of the U.S.
Quidel develops and markets diagnostic solutions aimed at improving patient outcomes and offering economic benefits to the healthcare system. The company’s products are designed to detect and diagnose a host of critical diseases such as influenza, respiratory syncytial virus (“RSV”), herpes and thyroid disease.
Quidel’s revenues in third-quarter fiscal 2011 soared 17% year over year to $33.1 million, led by its tests for infectious diseases. The company registered healthy growth across its Strep A (up 10% year over year) and RSV (more than doubled year over year) product lines in the quarter.
During the quarter, Quidel entered into a deal with Alere Inc (ALR) which enabled it to end its future royalty obligations (to Alere) on its lateral flow products in exchange of payments totaling $29.5 million.
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