News ReleaseView printer-friendly version
Quidel Receives Approval to Market Influenza Test in Canada
SAN DIEGO, May 4 /PRNewswire/ -- Quidel Corporation (Nasdaq: QDEL) today announced the receipt of a Medical Device License for the QuickVue(R) Influenza Test in accordance with the Canadian Medical Device Regulations. These regulations, similar to the U.S. Food and Drug Administration (FDA) regulations, ensure the safety and efficacy of medical devices available to the Canadian market. All class II or higher medical devices must be licensed in Canada prior to sale.
"The QuickVue Influenza Test can significantly aid in the diagnosis of influenza in patients presented with acute upper respiratory illness. This 10-minute test can quickly and accurately diagnose influenza -- helping the physician differentiate between other upper respiratory infections that may initially exhibit similar symptoms to the flu," said Lin Haelewyn, Vice President, Commercial Operations. "With the introduction to the market of several therapeutic drugs to treat the flu, the QuickVue Influenza Test enables the physician to prescribe the most effective therapeutic regimen."
Quidel's 10-minute QuickVue Influenza Test is now registered in the United States, United Kingdom, Canada, Switzerland, Germany and Italy.
Quidel's QuickVue Influenza Test is complimentary to Quidel's Group A strep and Infectious Mononucleosis products to aid the health care professional in the differential diagnosis of upper respiratory illnesses. Because early symptoms of all three diseases are generally similar, particularly in the pediatric patient population, Quidel's infectious disease products can provide a rapid diagnosis allowing for appropriate therapy decisions to be made quickly.
Quidel is a market leader in point-of-care, rapid diagnostics, providing simple, accurate and cost-effective diagnostic tests to physicians and/or consumers. QDEL's Test and Treat products are easy to use and provide results in minutes facilitating rapid treatment and improve health outcomes, lower costs, and increase patient satisfaction. Its core products address issues relating to a woman's health throughout her life including reproductive status, pregnancy management and osteoporosis. In addition, the Company provides diagnostic products for all family members for common health problems and infectious diseases, including influenza A and B, strep throat, H. pylori infection, chlamydia and infectious mononucleosis. Quidel's products are sold to healthcare professionals for use in physicians' offices, clinical laboratories, pharmacies, and wellness screening centers. Quidel also manufactures a line of products sold to consumers through organizations that provide store branded products.
This press release contains forward-looking statements regarding Quidel's future activities within the meaning of the federal securities laws. These forward-looking statements involve material risks and uncertainties. Many possible factors could affect the future results and performance of Quidel's products, such that actual results and performance may differ materially. If Quidel's products fail to perform as expected, or if there is lower consumer demand for these products than expected, Quidel's financial condition and operating results may be materially and adversely affected. Quidel's financial condition and operating results may also be materially and adversely affected by a number of other factors, including, without limitation, seasonality, adverse changes in competitive and economic conditions, currency fluctuations, actions by the Company's distributors, manufacturing and production delays or difficulties and adverse actions or delays in product reviews by the FDA. Please see the discussion of these and other factors in Quidel's annual reports on Form 10-K and subsequent quarterly reports on Form 10-Q. For more information, please visit Quidel's web site at http://www.quidel.com.
Charles J. Cashion, Chief Financial Officer, 858-552-7962,
or Margaret Kuhn, Director, Investor Relations, 858-646-8031,
both of Quidel Corporation