News ReleaseView printer-friendly version
Quidel Receives CE Mark for Its Sofia(R) RSV Fluorescent Immunoassay (FIA) Test
Sep 18, 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 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.
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.
Chief Financial Officer
Media and Investors Contact: