Quidel Receives CE Mark for Its New Sofia(R) Fluorescent Immunoassay for Diagnosis of Pneumococcal Pneumonia and Pneumococcal Meningitis

Quidel Corporation

, a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that it has received the CE Mark for Quidel's Sofia® S. pneumoniae Fluorescent Immunoassay (FIA) for use with the Sofia Fluorescent Immunoassay Analyzer. The Sofia S. pneumoniae FIA enables the rapid, qualitative detection of Streptococcus pneumoniae antigen in the urine of patients with pneumonia and in the cerebral spinal fluid (CSF) of patients with meningitis. Test results aid in the diagnosis of both pneumococcal pneumonia and pneumococcal meningitis. Streptococcus pneumoniae (SPN) is the leading cause of community-acquired pneumonia.1, 2 SPN can cause a wide spectrum of illnesses from upper respiratory tract infection to invasive pneumococcal disease. SPN infection is also associated with high mortality -- an estimated 1.6 million people die of pneumococcal diseases each year worldwide and approximately 1 million of these deaths are in children under five years of age.3 Pneumococci also cause over 50% of all cases of bacterial meningitis in the United States.4 Bacterial meningitis is usually severe, leading to complications such as brain damage, hearing loss, or learning disabilities. Antibiotic treatment for bacterial meningitis can be effective and should be started as soon as possible to limit or prevent these complications and to reduce the risk of death from meningitis.5 The Sofia S. pneumoniae FIA is an immunofluorescence-based lateral flow test that supports the diagnosis of pneumococcal pneumonia or pneumococcal meningitis in 10 minutes. The CE mark allows Quidel to launch the new Sofia assay in advance of the peak season in Europe and in other locations outside the United States. The product is currently not for sale in the U.S. "We are very pleased to receive CE Mark for our Sofia S. pneumoniae FIA for the European market," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "The combination of Sofia tests for the two leading community acquired pneumonias in Europe -- Streptococcus pneumonia and Legionella pneumophila -- both using the same specimen, both giving results in 10 minutes, and both available in the E.U. opens up an exciting new market opportunity for us that will enhance our already successful and expanding Sofia platform usage around the world." Quidel currently offers four other Sofia assays with the CE Mark: Influenza A+B, RSV, Strep A+ and Legionella. 1. Etiology of Community-Acquired Pneumonia: Increased Microbiological Yield with New Diagnostic Methods, N. Johansson et al., CID 2010:50. 2. Guidelines for management of community-acquired pneumonia in adults, G. Lopardo et al., Medicina (B Aires). 2015; 75(4):245-257. 3. Streptococcus pneumoniae nasopharyngeal colonisation in children aged under six years with acute respiratory tract infection in Lithuania, V Usonis et al, Eurosurveillance, Volume 20, Issue 13, 02 April 2015. 4. Pneumococcal Disease: Epidemiology and Prevention of Vaccine-Preventable Diseases, CDC The Pink Book: 13th Edition (2015). 5. Bacterial meningitis in the United States, 1998-2007, M. C. Thigpen et al., N Engl J Med. 2011