Quidel’s Influenza Test Receives FDA Clearance

Quidel Corporation has announced that it has received FDA clearance for the sale of its next generation immunoassay analyzers. The Sofia analyzer and Sofia Influenza A+B Fluorescence Immunoassay (FIA), combine unique software and fluorescent chemistry to give automatic and objective results.

The Sofia FIA employs advanced lateral flow and Immunofluorescence technologies to provide enhanced clinical sensitivity for influenza A and B. The Sofia Analyzer can accommodate both large and small laboratories using different operational modes, and additional features enable its use in a variety of healthcare settings, from hospitals to small clinics.

"We are very pleased with the FDA clearance of our Sofia Analyzer and Sofia Influenza A+B FIA," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "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 which will be available for the diagnosis of infectious disease as well as other conditions and disorders, using the Sofia Analyzer. The FDA clearance grants Quidel permission to sell both the Sofia Analyzer and the Sofia Influenza A+B FIA in the United States in advance of the upcoming influenza and respiratory disease season. Both the Sofia Analyzer and the Sofia Influenza A+B FIA received the CE Mark in August 2011, and are thus already available for sale in Europe and other ex-U.S. locations, and they are now available for commercial distribution in the United States.