Quidel Corporation (NASDAQ:QDEL), a leading provider of rapid diagnostic testing solutions, announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for the sale of its QuickVue ® RSV 10, a lateral flow immunoassay test for the qualitative detection of acute respiratory syncytial virus (RSV) infections.
Almost all infants will suffer from an RSV infection before the age of two. According to the United States Centers for Disease Control and Prevention, RSV is the most common cause of bronchiolitis and pneumonia in children under one year of age in the United States resulting in between 75,000 and 125,000 children hospitalized annually because of an RSV infection. 1, 2
QuickVue RSV 10 detects RSV antigen directly from nasopharyngeal swab and nasopharyngeal aspirate/wash specimens from symptomatic patients under the age of six.
“The signs of an RSV infection are often similar to other respiratory infections, and diagnosis by symptoms alone can be difficult. Our new QuickVue RSV 10 product is a reliable, easy-to-use aid in detecting RSV in children. This new product will be available for the upcoming RSV season, which normally begins in November,” said Douglas Bryant, president and chief executive officer of Quidel Corporation. “QuickVue RSV 10 offers results in 10 minutes, which can provide a significant time savings to healthcare professionals.”QuickVue RSV 10 employs the identical test method and sample preparation of the QuickVue ® Influenza A+B test, allowing for the use of the same nasopharyngeal patient specimen when testing for influenza or an RSV infection. 1Centers for Disease Control and Prevention website: http://www.cdc.gov/rsv/about/faq.html 2March of Dimes website: http://www.marchofdimes.com/pnhec/298_9546.asp 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 leading brand names QuickVue®, D 3® Direct Detection and Thyretain™, Quidel's products aid in the detection and diagnosis of many critical diseases and conditions, including 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 www.quidel.com and Diagnostic Hybrids at www.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 comply with the covenants in our senior credit facility, our ability to develop new products and technologies, 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, 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, including as a result of currency fluctuations, political instability or new or increased tariffs, potential inadequacy of booked reserves and possible impairment of goodwill, and lower-than-anticipated 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.