News ReleaseView printer-friendly version
Quidel Receives CE Mark for Its Sofia(R) Legionella Fluorescent Immunoassay (FIA)
Nov 07, 2012 (Marketwire via COMTEX) --Quidel Corporation (NASDAQ: QDEL), 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
About Quidel Corporation
Quidel Corporation serves to enhance the health and well being of people around the globe through the development of diagnostic solutions that can lead to improved patient outcomes and provide economic benefits to the healthcare system. Marketed under the QuickVue®, D3® Direct Detection and Thyretain® leading brand names, as well as under the new Sofia® brand, Quidel's products aid in the detection and diagnosis of many critical diseases and conditions, including, among others, influenza, respiratory syncytial virus, Strep A, herpes, pregnancy, thyroid disease and fecal occult blood. Quidel's research and development engine is also developing a continuum of diagnostic solutions from advanced lateral-flow and direct fluorescent antibody to molecular diagnostic tests to further improve the quality of healthcare in physicians' offices and hospital and reference laboratories. For more information about Quidel's comprehensive product portfolio, visit quidel.com and Diagnostic Hybrids at dhiusa.com.
This press release contains forward-looking statements within the meaning of the federal securities laws that involve material risks, assumptions and uncertainties. Many possible events or factors could affect our future financial results and performance, such that our actual results and performance may differ materially from those that may be described or implied in the forward-looking statements. As such, no forward-looking statement can be guaranteed. Differences in actual results and performance may arise as a result of a number of factors including, without limitation, seasonality, the timing of onset, length and severity of cold and flu seasons, the level of success in executing on our strategic initiatives, our reliance on sales of our influenza diagnostic tests, uncertainty surrounding the detection of novel influenza viruses involving human specimens, our ability to develop new products and technology, adverse changes in the competitive and economic conditions in domestic and international markets, our reliance on and actions of our major distributors, technological changes and uncertainty with research and technology development, including any molecular-based technology, the medical reimbursement system currently in place and future changes to that system, manufacturing and production delays or difficulties, adverse actions or delays in product reviews by the U.S. Food and Drug Administration (the "FDA"), our ability to comply with FDA, environmental and other regulations, our ability to meet unexpected increases in demand for our products, our ability to execute our strategy, including the integration of new companies or technologies, disruptions in the global capital and credit markets, our ability to hire key personnel, intellectual property, product liability, environmental or other litigation, potential required patent license fee payments not currently reflected in our costs, adverse changes in our international markets, potential inadequacy of booked reserves and possible impairment of goodwill, and lower-than-anticipated acceptance, sales or market penetration of our new products. Forward-looking statements typically are identified by the use of terms such as "may," "will," "should," "might," "expect," "anticipate," "estimate," and similar words, although some forward-looking statements are expressed differently. The risks described under "Risk Factors" in reports and registration statements that we file with the SEC from time to time should be carefully considered. You are cautioned not to place undue reliance on these forward-looking statements, which reflect management's analysis only as of the date of this press release. We undertake no obligation to publicly release the results of any revision or update of the forward-looking statements, except as required by law.
Quidel Contact: Quidel Corporation Randy Steward Chief Financial Officer (858) 552-7931 Media and Investors Contact: Quidel Corporation Ruben Argueta (858) 646-8023 Email Contact