Quidel Corporation (ticker: QDEL, exchange: NASDAQ Global Market (.O))
News Release -
18-Aug-1999
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.
CONTACT:
Charles J. Cashion, Chief Financial Officer, 619-552-7962,
or Christa Cerciello, Investor Relations, 619-646-8031,
both of QUIDEL Corporation |