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QUIDEL Receives FDA Clearance for Improved H. Pylori Diagnostic Test; Good News for Ulcer Sufferers
SAN DIEGO, Aug. 18 /PRNewswire/ -- QUIDEL Corporation (Nasdaq: QDEL) announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) to market a second generation point-of-care rapid diagnostic test for the detection of Helicobacter pylori (H. pylori). The redesigned diagnostic test provides quicker results and is performed on a smaller blood sample compared with QUIDEL's existing H. pylori test. Over 80% of peptic ulcer disease cases are believed to be associated with H. pylori infection.
"We are pleased to have received clearance to market our new H. pylori diagnostic test," said Charles H. Bowden, M.D., chief medical officer and vice president, infectious diseases at QUIDEL Corporation. "Rapid diagnostic testing for H. pylori is a growing market, and this new test will allow physicians to more quickly and easily diagnose the existence of H. pylori infection."
QUIDEL Corporation discovers, develops, manufacturers and markets point-of-care rapid diagnostics for women's health and infectious diseases. These products provide simple, accurate and cost-effective diagnoses for acute and chronic conditions. QUIDEL's products are sold to professionals in the physician's office and clinical laboratory, and to consumers through organizations that provide private label, store brand products. For more information on QUIDEL, please visit the web site at http://www.quidel.com.
This press release contains forward-looking statements regarding QUIDEL and its future sales-related activities within the meaning of the federal securities laws that involve material risks and uncertainties. Many factors could affect future financial results and performance, such that actual results and performance may differ materially. Operating results may also be affected due to a number of factors, including, without limitation, QUIDEL's ability to reduce costs through consolidation of operations, seasonality, adverse changes in competitive and economic conditions in domestic and international markets, actions of major distributors, manufacturing and production delays or difficulties, adverse actions or delays in product reviews by the FDA, and the lower acceptance of QUIDEL's new products than forecast. Please see the discussion of these factors in the company's annual reports, Form 10-K's and subsequent quarterly reports on Form 10-Q.
Charles J. Cashion, Chief Financial Officer, 619-552-7962,
or Christa Cerciello, Investor Relations, 619-646-8031,
both of QUIDEL Corporation