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|Quidel's QuickVue(R) Influenza Test Launched in Japan|
SAN DIEGO, Oct. 10 /PRNewswire/ -- Quidel Corporation (Nasdaq: QDEL), a leading provider of rapid point-of-care (POC) diagnostic tests, today announced that its QuickVue(R) Influenza test product is now being sold throughout Japan by the Company's exclusive Japanese distributor, Sumitomo Seiyaku Biomedical Co., Ltd., as the RapidVue(R) Influenza A/B test. The launch of this product follows receipt of a reimbursement code effective October 1, 2001 and product approval on May 7, 2001.
The Company also announced that recent improvements to the QuickVue Influenza test allow it to be stored at room temperature and with no special handling or storage requirements for up to two years from the date of manufacture.
"We estimate the global rapid influenza testing market at $23 million last year, and with the recent introduction of influenza therapeutics and with expanded use of testing products worldwide, we believe this market is poised for significant growth," said S. Wayne Kay, Quidel's president and chief executive officer. "RapidVue Influenza A/B is the first rapid test for these two common strains of influenza to be launched in Japan, where a therapeutic drug for influenza type A and another drug for types A and B became reimbursable in 1998 and 2001, respectively."
In Japan, sales of branded pharmaceuticals for treating influenza type A and B were approximately 6 billion yen (approx. $50 million), roughly one quarter the amount spent in an average year due to the mild 2000 -- 2001 flu season.
"But these drugs are only effective when the patient's ailment has been properly diagnosed as influenza, as opposed to any one of a number of bacterial and viral infections presenting with similar clinical symptoms," he added. "In recent years, mutant viruses made the detection and treatment of influenza more critical. For example, in 1997-1998 influenza type A was spread throughout Japan, resulting in the death of many infants due to acute encephalopathy and cerebritis."
Developed through a funded collaboration with GlaxoSmithKline, the QuickVue Influenza test is a rapid, three-step, one-reagent diagnostic test for the detection of influenza type A and B antigens, the two most common types of the virus. The test is simple to use, does not require special instruments and provides accurate results in 10 minutes or less in an easy-to-read, user-friendly format. The test detects influenza type A and type B viruses in the nasal cavity of patients with greater sensitivity and specificity than conventional influenza virus diagnostics.
The test received FDA clearance in September 1999, selling efforts in the U.S. began in December 1999 and the product received CLIA-waived status in October 2000. The QuickVue Influenza test also is available over-the-counter to consumers in the United Kingdom, Germany and Italy.
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 (both domestically and internationally) in competitive and economic conditions, 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 report on Form 10-K and subsequent quarterly reports on Form 10-Q.