FDA approves Quidel's influenza test

The U.S. Food and Drug Administration has approved the sale of Quidel Corporation's next generation immunoassay analyzers for influenza.
The Sofia Analyzer and the Sofia Influenza A+B Fluorescence Immunoassay combine fluorescent chemistry with unique software to give objective and automatic results in testing for influenza.
The Sofia FIA employs immunofluorescence and advanced lateral flow technologies to provide increased clinical sensitivity for influenza A and B. The Sofia Analyzer is able to accommodate large and small laboratories utilizing different operational modes and. Some additional features allow its use in a variety of healthcare settings, including small clinics and hospitals.
"We are very pleased with the FDA clearance of our Sofia Analyzer and Sofia Influenza A+B FIA," Douglas Bryant, the president and chief executive officer of Quidel Corporation, said. "This announcement represents the achievement of a significant milestone, and positions us in the marketplace with a strategically important platform that will provide numerous benefits to healthcare providers and their patients."
The Sofia Influenza A+B FIA is the first in a series of new Quidel FIA's that will be available for diagnosing infectious disease in addition to other conditions and disorders. The FDA clearance gives Quidel, a manufacturer of diagnostic healthcare solutions, the permission to sell both the Sofia Analyzer and the Sofia Influenza A+B FIA in the United States. The products are already available for sale in Europe and other non-U.S. locations.