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|Quidel Comments on New Product Launches and Second Quarter Earnings|
SAN DIEGO, June 27 /PRNewswire/ -- Quidel announced today that, as part of an on-going integration of the urinalysis product line acquired from Dade Behring, it has received CLIA-waived classification of the QuickVue(TM) UrinChek urinalysis product from the U.S. Food and Drug Administration, under the Clinical Laboratory Improvement Amendment of 1988 (CLIA). The CLIA-waived status allows a broad base of physicians to perform the test at the point-of-care setting, further complementing Quidel's existing point-of-care business.
The QuickVue UrinChek urinalysis product is an important tool available to the physician for overall assessment of patient health. The test is simple to use and provides results in an easy-to-read dipstick format. The Company will launch the QuickVue product line in the United States in the third quarter, rather than the second quarter as originally planned.
"This decision about the timing of the product launch enables us to ensure a higher quality market introduction in the U.S., but has the downside of impacting our second quarter results," said Andre de Bruin, President and Chief Executive Officer. "We continue to be very excited by the prospects for this new business opportunity and its expected contribution to sales and earnings in the quarters ahead. We also expect to launch the improved, CLIA-waived H. pylori test in the third quarter."
The Company also reported that, despite an ongoing manufacturing backlog of pregnancy tests, product sales for the second quarter continue at levels well above the previous year but below estimates. In addition to expenses associated with the launch of the new products, expenses associated with currency exchange rates (due to the strength of the U.S. Dollar compared with currencies of Quidel's European subsidiaries) will also impact earnings. The combined effect of these events is expected to produce pretax results at, or below, breakeven for the quarter.
"The revenue shortfall during the second quarter is expected to benefit third quarter results. The demand for Quidel's products remains strong and, with the introduction of the QuickVue UrinChek and H. Pylori products, the prospects for expected annual profits remain intact," said Andre de Bruin.
Quidel Corporation discovers, develops, manufactures and markets point-of-care, rapid diagnostic tests for detection of medical conditions and illnesses. These products provide accurate, rapid and cost-effective diagnostic information for acute and chronic conditions that affect women's health throughout the phases of their lives including reproductive status, pregnancy management and osteoporosis. Quidel also provides point-of-care diagnostics for 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 and pharmacies, and to consumers through organizations that provide private label, store brand products. These tests provide diagnostic information to enable rapid treatment and improve health outcomes, lower costs, and increase patient satisfaction.
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, foreign currency fluctuation, 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.