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QUIDEL FILES FOR FDA MARKETING CLEARANCE FOR RAPID FECAL OCCULT BLOOD TEST

 SAN DIEGO, Feb. 17 /PRNewswire/ -- QUIDEL Corp. (NASDAQ: QDEL) today said it has filed a 510(k) submission with the U.S. Food and Drug Administration (FDA) for clearance to market its new rapid immunoassay called QuickVue(TM) One-Step Fecal Occult Blood Test (FOB). This newest QuickVue product is a rapid, two-minute test that allows doctors and laboratories to detect hidden blood in stool samples, which is considered an important first step in the early detection of many gastrointestinal disorders, including colorectal cancer.
 The American Cancer Society recommends that all asymptomatic, low-risk patients over the age of 40 years be routinely tested for fecal occult blood as part of their annual physical examination. Higher risk patients should begin testing at an earlier age. Colorectal cancer is one of the most deadly forms of cancer and is second only to lung cancer. Survivability is greatly increased through early detection.
 The QuickVue FOB Test has the distinct advantage of improved specificity and sensitivity over the most widely used tests which employ guaiac-based chemistry. Guaiac-based tests frequently elicit false positive results from diets that include red meats, fruits or vegetables with high peroxidase content, and certain vitamin preparations containing iron. Conversely, vitamin C and other drugs can inhibit guaiac-based tests causing false negative results. To avoid erroneous results, patients must adhere to strict dietary measures two days before testing. As a consequence, patient compliance problems exist, and a large number of the tests are repeated. The QuickVue FOB Test circumvents the dietary restrictions and compliance problems associated with guaiac-based tests because it is very specific for human hemoglobin found only in human red blood cells.
 "Compliance problems associated with guaiac-based tests have resulted in needless patient anxiety from false positive results," said Scott L. Glenn, chairman and chief executive officer of QUIDEL. "The new QuickVue FOB Test improves upon an accepted method of screening for colon problems which we believe will increase the quality of patient care while eliminating redundant testing. We are pleased to have developed this test in conjunction with our Japanese partner, Fujirebio Inc., and look forward to their successful market launch in Japan while we market the test in the United States and Europe through our own professional sales force and distribution network."
 QUIDEL Corp. develops, manufactures and markets rapid, immunodiagnostic products that provide simple, accurate and cost- effective diagnoses in the areas of human fertility, infectious diseases, allergy and autoimmune disorders. These tests are designed for use in the physician's office, clinical laboratory and home testing markets.
 -0- 2/17/93
 /CONTACT: Scott L. Glenn, chairman and CEO, 619-552-7900, or Mark Francois, manager-investor relations, 619-552-7931, both of QUIDEL/
 (QDEL)


CO: QUIDEL Corp. ST: California IN: MTC SU:

LS-JL -- SD002 -- 7125 02/17/93 08:10 EST
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Date:Feb 17, 1993
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