Quidel Corporation, a leading provider of diagnostic testing solutions and cellular-based virology assays, announced today that it has received the CE Mark for its Sofia Legionella FIA for use on the Sofia Analyzer for the rapid detection of Legionnaires' disease, also known as legionellosis.
The Gram-negative bacterium, Legionella pneumophila, is the cause of this life-threatening respiratory illness. The symptoms of Legionnaires' disease mimic those commonly associated with influenza, including headache, fever, muscle pain, and chills in the first day, but gradually expand to include cough and shortness of breath by day three. If diagnosed early in the infection, this disease can be effectively treated with antibiotics, but if left untreated, the disease can be fatal, especially among elderly and immunocompromised patients. In 2009, the European Center for Disease Prevention and Control reported nearly 6,000 cases of Legionnaires' disease, but stated that the actual number of cases in Europe was likely significantly under-reported.(1) In the United States, where the incidence of Legionnaires' disease has tripled in the last decade, the disease accounts for nearly 8,000 to 18,000 hospitalizations per year.(2)
Sofia is the brand name for Quidel's next generation, immunoassay system that was launched earlier this year. The Sofia Analyzer and Sofia Legionella 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 ten (10) minutes of application of the patient's specimen. The Sofia system 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.
The CE Mark allows Quidel to launch its new Sofia Legionella FIA in Europe.
"We are extremely pleased to announce the CE Mark and impending launch of our fourth Sofia assay in Europe," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "The Sofia Legionella FIA will provide customers with an accurate, ten-minute solution for the diagnosis of Legionnaires' disease. Receiving the CE Mark is another milestone testifying to the promise of the aggressive development program we instituted nearly three years ago -- one achievement of which is the unique Sofia immunofluorescence platform and system."
The Sofia Legionella assay uses the Sofia Analyzer, an instrument that is designed to easily incorporate new analyte-specific algorithms -- an important feature as the Sofia menu of products expands. The other Sofia immunoassays presently for sale in Europe include FIAs for Influenza A+B, Strep A and RSV.
(1) Risk for Travel-associated Legionnaires' Disease, Europe, 2009 http://wwwnc.cdc.gov/eid/article/18/11/12-0496_article.htm#r6
(2) Patient Facts: Learn More about Legionnaires' disease http://www.cdc.gov/legionella/patient_facts.htm