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|Quidel Launches Tests for Infectious Vaginitis, QuickVue(R) Advance pH and Amines and QuickVue(R) Advance G. Vaginalis Tests|
Quidel's First Commercial Application of Revolutionary LTF(TM) Technology
ORLANDO, Fla., Jul 29, 2002 /PRNewsire-FirstCall via Comtex/ -- Quidel Corporation (Nasdaq: QDEL), a leading provider of rapid point-of-care (POC) diagnostic tests, announced today at the American Association for Clinical Chemistry's (AACC) 54th Annual Meeting and Clinical Lab Expo the launch of two tests for the clinical evaluation of infectious vaginitis. The launch represents the first commercial application of Quidel's patented and revolutionary LTF(TM) (Layered Thin Film) technology under the brand names, QuickVue(R) Advance pH and Amines and QuickVue(R) Advance G. vaginalis tests.
"This is an important milestone for Quidel as it signals the beginning of many products to be developed and marketed under this new platform, LTF(TM)", said S. Wayne Kay, president and chief executive officer. "Our focus is on the future development of other rapid assays on LTF(TM) as we maintain and expand our leadership in the POC market."
The first two tests address infectious vaginitis, an area where many women's health needs are still going unmet. "These tests represent the future of POC (point-of-care) testing and reflect Quidel's commitment to advanced technologies. They will give physicians objective and rapid test results that are very easy to interpret," said Bill Elliott, executive vice president for Quidel.
About LTF(TM) (Layered Thin Film) Technology
This year, Quidel Corporation, the leading manufacturer of rapid point-of-care (POC) tests for the physician's office introduced the revolutionary new LTF(TM) (layered thin film) technology. An easy to read, extremely precise test platform, LTF(TM) tests are as small and thin as a credit card. Vigorous efforts are underway to enter strategic alliances to commercialize this proprietary technology and the first two of several products in development are marketing under the QuickVue(R) Advance brand: pH and Amines test and G. vaginalis test.
About the QuickVue(R) Advance pH and Amines and the QuickVue(R) Advance G. vaginalis tests
Infectious vaginitis is the number one reason why women visit a physician and until now testing to evaluate for bacterial vaginosis was limited to using the microscope. The QuickVue Advance pH and Amines test identifies vaginal pH less than 4.7 from vaginal pH equal to or greater than pH 4.7 and detects volatile amines associated with anaerobe overgrowth. With the QuickVue(R) Advance pH and Amines test, which is CLIA-waived, any healthcare professional can run the test at point-of-care, which will allow more patients to benefit from rapid diagnosis and to receive the most appropriate treatment for their conditions at the point of care. The test contains two qualitative colorimetric tests for use in the characterization of vaginal fluid, a pH test and a test that detects alkali volatilizable amines. Combined with the evaluation of the vaginal discharge, these tests provide three of the four clinical or Amsel criteria necessary for the evaluation of bacterial vaginosis. Test results are read within 2 minutes as a plus (+) or minus (-) read-out.
The QuickVue Advance G. vaginalis test detects Gardnerella vaginalis Proline IminoPeptidase (PIP) enzyme activity from women suspected of having bacterial vaginosis (BV). The QuickVue(R) Advance G. vaginalis test is simple run, contains quality control on each and every test, and results are read within 5 minutes. This new test is an enzyme activity test for use in the detection of Gardnerella vaginalis Proline IminoPeptidase (PIP) activity in vaginal fluid specimens from women suspected of having bacterial vaginosis, or BV. With this Rub 'n Read(TM) test, results are read directly on the swab, which turn peach to pink to red.
As with all of Quidel's rapid POC tests, these new tests help improve women's health, which is the mission of the Company: Helping Women and Their Families Live Healthy Lives.
Quidel Corporation, a worldwide company helping women and their families live healthy lives, discovers, develops, manufactures and markets rapid point-of-care diagnostic tests for detection of medical conditions and illnesses. These products provide accurate, rapid and cost-effective diagnostic information for acute and chronic conditions associated with women's health in areas such as reproduction and diseases of the elderly. Quidel also provides point-of-care diagnostics for infectious diseases, including influenza A and B, Strep throat, H. pylori infection, chlamydia, infectious mononucleosis and bacterial vaginosis. Quidel's products are sold to healthcare professionals for use in physician offices, clinical laboratories and pharmacies, and to consumers through organizations that provide private label, store brand products. These tests provide diagnostic information that enables rapid treatment and improves health outcomes, lowers costs and increases patient satisfaction. For more information, please visit Quidel's Web site at http://www.quidel.com .
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, 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. For more information, please visit Quidel's web site at http://www.quidel.com .