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QUIDEL SEEKS FDA MARKETING CLEARANCE FOR ONE-STEP STREP TEST

 SAN DIEGO, Sept. 15 /PRNewswire/ -- QUIDEL Corp. (NASDAQ: QDEL), a leading developer and marketer of rapid diagnostic tests, today said it has filed with the United States Food and Drug Administration (FDA) for clearance to market its new QuickVue(R) One-Step Strep A Test to laboratories and doctors' offices. U.S. sales of rapid diagnostic Strep A tests are between $50 million to $100 million per year.
 QUIDEL's new test is a one-step procedure using throat swabs that gives results in as fast as five minutes from a single step. Other tests currently on the market often require as many as five or six different and sometimes timed steps. In addition, the new QuickVue(R) test is the only rapid strep test to offer the convenience of "in-line" or in-device extraction of throat swabs which are typically performed as a separate and less convenient step in other assays. These features give the busy doctor's office the convenience to "walk away" once the test is started.
 The new QuickVue(R) test is a lateral flow immunoassay that contains a highly specific and sensitive antibody that is reactive to Group A Streptococci, the germ responsible for common strep throat. Left untreated, infection from Strep A can develop into more serious later stage complications that include rheumatic fever. The best means to avoid these complications is rapid diagnosis followed by rapid treatment with the appropriate antibiotics.
 "As one of the leading developers and manufacturers involved in the rapid strep testing market, we believe this test will offer superior convenience over other tests available and look forward to a warm reception in the marketplace for our newest QuickVue(R) product for this critical and common infection," said Scott L. Glenn, chairman and chief executive officer of QUIDEL.
 "Our research team," Glenn continued, "first broke ground on this important project 13 months ago. To have completed all necessary development, scale-up, manufacturing transfers, and now the FDA filing in such a short amount of time is quite an accomplishment."
 QUIDEL Corp. develops, manufactures, and markets rapid immunodiagnostic products for family planning and family care. These products, which provide simple, accurate and cost-effective diagnoses in the areas of human fertility, infectious diseases, allergy, and autoimmune disorders, are designed for use in the physician's office, clinical laboratory and home testing markets.
 -0- 9/15/93
 /CONTACT: Scott L. Glenn, chairman and CEO, 619-552-7900, or Mark Francois, director-investor relations, 619-552-7931/
 (QDEL)


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

LS-LM -- SD002 -- 2066 09/15/93 08:03 EDT
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Publication:PR Newswire
Date:Sep 15, 1993
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