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|Quidel Receives Additional Patent Protection on LTF Technology; Patent Covers Use of Company Technology to Detect Vaginal Clue Cells|
SAN DIEGO, Aug. 2 /PRNewswire/ -- Quidel Corporation (Nasdaq: QDEL), a leading provider of point-of-care (POC) rapid diagnostic tests, today announced receipt of additional patent protection for its Layered Thin Film (LTF) Technology. The recently issued U.S. Patent, No. 6,200,817 B1, covers the use of proprietary Quidel LTF technology to detect vaginal clue cells present in bacterial vaginosis (BV) quickly, easily and accurately in point- of-care settings.
Clue cells are vaginal epithelial cells covered with anaerobic bacteria, the presence of which indicates a major, pathological disruption of the protective normal vaginal microflora. These cells can be found in vaginal fluid specimens of women suffering from the most common form of infectious vaginitis, bacterial vaginosis.
"Until recently, the detection of vaginal clue cells required time- consuming microscopic evaluation of vaginal fluid specimens," said S. Wayne Kay, Quidel's President and Chief Operating Officer. "While vaginal clue cells are the most specific indicator of BV, their detection by microscope is subjective, highly dependent on the skill and training of the microscopist, and not well suited to the majority of physician offices. As a result, BV is currently under-diagnosed, despite its strong association with premature labor, low-birth-weight babies, post-surgical infections, and increased risk of sexually transmitted diseases, including HIV."
The patented Quidel LTF technology permits a new method for simple, rapid, cost-effective and accurate detection of vaginal clue cells at the point of care. Quidel's research demonstrates that vaginal fluid amines can be surrogate markers for the presence of vaginal clue cells and that these amines can be detected quickly and easily with the Company's patented test for volatile amines. The Company is completing the development of a panel of tests for infectious vaginitis that is expected to be launched in 2002.
Worldwide, there are over 48 million office visits annually for bacterial vaginosis (BV). BV is the most prevalent cause of vaginal discharge, and half of all women whose illnesses meet the clinical criteria for BV are asymptomatic. Because of this, incidence rates are likely closer to 100 million cases annually.
Worldwide, the average incidence of BV in women of reproductive age is approximately 20%.
About Quidel Corporation
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 business, 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.