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Quidel Receives CLIA-Waived Status for H. pylori Diagnostic Test
SAN DIEGO, Sept. 2 /PRNewswire/ -- Quidel Corporation (Nasdaq: QDEL) today announced the availability of the improved QuickVue(R) One-Step H. pylori II Test for use in waived physician office laboratories, under the Clinical Laboratory Improvement Amendment of 1988 (CLIA). The QuickVue(R) One-Step H. pylori II Test for use with whole blood samples, received waived categorization from the Centers for Disease Control and Prevention. This waived status allows most physicians to perform the test at the point-of-care.
The improved QuickVue(R) One-Step H. pylori II Test is a rapid, qualitative detection test for Helicobacter pylori (H. pylori), an infection implicated in over 80% of peptic ulcer disease cases. The improved test is simple to use and provides results in approximately 5 minutes in an easy to read, two-color result format.
The QuickVue(R) One-Step H. pylori II Test is another addition to Quidel's family of CLIA-waived infectious disease tests. The other tests include the QuickVue(R) In-Line(R) One-Step Strep A Test, the QuickVue(R) One-Step H. Pylori Test and the CARDS(R) O.S. (R) Mono Test.
Quidel Corporation discovers, develops, manufactures and markets point-of-care rapid diagnostic products for detection of human medical conditions and illnesses. These products provide simple, accurate and cost-effective diagnoses for acute and chronic conditions for women's health throughout the phases of their lives in the areas of reproductive status, pregnancy management and osteoporosis. Quidel also provides a line of point-of-care diagnostics for infectious diseases, including strep throat, H. pylori, chlamydia and mononucleosis. Quidel's products are sold to professionals in the physician's office and clinical laboratories, and to consumers through organizations that provide private label, store brand products. The products allow an accurate diagnosis in the physician's office, pharmacy or patient's home and enable rapid treatment, resulting in improved health outcomes, lower costs, and increased patient satisfaction.
This press release contains forward-looking statements regarding Quidel, its products and its 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 factors, including, without limitation, seasonality, adverse changes 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 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, 619-552-7962,
or Christa Cerciello, Investor Relations, 619-646-8031,
both of Quidel Corporation