Quidel Corporation, a leading provider of diagnostic testing solutions and cellular-based virology assays, announced that it has received the CE Mark for its Sofia RSV FIA for use on the Sofia Analyzer for the rapid detection of respiratory syncytial virus (RSV).
Sofia is the brand name for Quidel's next generation, immunoassay system that was launched earlier this year. The Sofia Analyzer and Sofia RSV FIA combine unique fluorescent chemistry, advanced lateral flow technology, and failure alert and fail-safe systems to ensure a reliable, objective, highly accurate, and rapid diagnostic result. The Sofia system was 510(k) cleared in October of 2011 and received Clinical Laboratory Improvement Amendments (CLIA) waiver by the U.S. FDA in April of 2012.
With the CE Mark, Quidel is now launching its new Sofia RSV FIA in Europe. This effort is an important adjunct to its already-ongoing and very active sales and marketing activities in other parts of the world, including Asia, Africa, and the mid-East. This RSV assay is presently not for sale in the U.S.
"We are very pleased to receive the CE Mark for the Sofia RSV FIA. This product will help healthcare workers quickly detect this potentially severe respiratory disease of infants and young children, a disease which is sometimes confused with influenza. RSV is the third assay for infectious diseases available on the Sofia system and will soon be joined by other tests that are in development, expanding the system's utility and appeal worldwide," said Douglas Bryant, president and chief executive officer of Quidel Corporation.
Tim Stenzel, Quidel's Chief Scientific Officer, added, "RSV can be a severe respiratory illness of young children, and accounts for nearly 45% of all hospitalizations for children under two years of age with lower respiratory tract infections in Europe. This situation is similar in the United States where RSV infection is the most common cause of bronchiolitis and pneumonia in children under one year of age, accounting for approximately 125,000 hospitalizations each year. Given the significant morbidity and mortality associated with this disease, the CDC conducts surveillance for this illness throughout the year across all regions in the United States."
The Sofia RSV FIA uses the Sofia Analyzer, a CLIA-waived instrument that is designed to easily incorporate software upgrades for new analyte-specific algorithms as the Sofia menu of products expands. Sofia Influenza A+B FIA received the CE Mark in August of 2011 and Sofia Strep A FIA received the CE Mark in December of 2011.