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FDA Grants CLIA-Waived Status to Quidel's QuickVue Influenza A+B Test
SAN DIEGO--(BUSINESS WIRE)--Feb. 25, 2004--Quidel Corporation (Nasdaq:QDEL) today announced that its new QuickVue(R) Influenza test A+B has been granted a CLIA waiver from the U.S. Food and Drug Administration. The test provides physicians with a fast, accurate, easy-to-use method for aiding in the differential diagnosis of acute influenza type A or B.
Using a painless nasal swab or nasal aspirate sample, the test delivers results in 10 minutes or less. This simple test requires only 30 seconds of hands-on time, making it an ideal tool for physician office settings. Test kits can be stored at room temperature and have a shelf life of 24 months from date of manufacture.
"The key to treating influenza is the prompt and appropriate treatment at the point-of-care. The speed of diagnosis is important in all settings, but particularly important in urgent care settings where rapid and reliable treatment decisions can potentially minimize the spread of the disease," S. Wayne Kay, Quidel's president and chief executive officer, said.
The QuickVue Influenza A+B test is the newest member of the Quidel suite of CLIA-waived diagnostic tests for a wide range of infectious diseases that also includes, Strep A, Infectious Mononucleosis and H. pylori, which are marketed worldwide under the QuickVue brand. The QuickVue Influenza test A+B is a companion to the widely used, CLIA-waived QuickVue Influenza test, which has been available worldwide since 2001.
Quidel Corporation, a worldwide company helping women and their families live healthy lives, discovers, develops, manufactures and markets rapid point-of-care (POC) diagnostic tests for detection of medical conditions and illnesses. These products provide accurate, rapid and cost-effective diagnostic information for acute and chronic conditions associated with women's health in areas such as reproduction, upper respiratory infections and other clinical conditions. Quidel provides a broad line of point-of-care diagnostics for pregnancy and infectious diseases, including influenza A and B, Strep throat, pregnancy, H. pylori infection, chlamydia, infectious mononucleosis and infectious vaginitis. Quidel's products are sold to healthcare professionals for use in physician offices, clinical laboratories and to consumers through several distribution partners. For more information, please visit www.quidel.com.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the federal securities laws that involve material risks and uncertainties. Many possible events or factors could affect Quidel's future financial results and performance, such that its actual results and performance may differ materially. As such, no forward-looking statement can be guaranteed. Differences in operating results may arise as a result of a number of factors including, without limitation, seasonality, adverse changes in the competitive and economic conditions in domestic and international markets, actions of our major distributors, manufacturing and production delays or difficulties, adverse actions or delays in product reviews by the U.S. Food and Drug Administration, product liability, intellectual property, environmental or other litigation, and the lower acceptance of our new products than forecast. 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 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 of the forward-looking statements.
CONTACT: Quidel Corporation
Paul E. Landers, 858-552-7962
Lippert/Heilshorn & Associates
Ina McGuinness or Bruce Voss, 310-691-7100
SOURCE: Quidel Corporation