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Quidel Seeks FDA Clearance For Point-Of-Care Influenza Diagnostic
SAN DIEGO, May 13 /PRNewswire/ -- Quidel Corporation (Nasdaq: QDEL) announced today that it has filed a 510(k) application with the U.S. Food and Drug Administration (FDA) for a rapid, single step, point-of-care diagnostic test for the detection of influenza A and B. This product was developed under a fully-funded collaboration with Glaxo Group Ltd., a wholly owned subsidiary of Glaxo Wellcome, PLC. The purpose of the collaboration was to develop a rapid diagnostic test to assist healthcare professionals in the diagnosis and treatment of influenza at the point-of-care. Glaxo's drug Relenza(TM), for the treatment of influenza types A and B, has been approved in Sweden and recommended for approval in Australia with additional approvals pending throughout the world. Relenza(TM) is currently under review by the U.S. FDA.
"We are pleased to have reached this very significant milestone. Not only is there substantial commercial potential for a rapid test for influenza, but it also demonstrates QUIDEL's ability to successfully complete challenging development projects with large pharmaceutical partners," said Andre de Bruin, vice chairman, president and chief executive officer of QUIDEL.
Influenza impacts approximately 20-25 million people in the U.S. every year. Annually, influenza results in over 300,000 hospitalizations with estimated costs of $3-5 billion in the U.S. for related medical conditions and lost work time. Early diagnosis is expected to help identify patients who would benefit from immediate therapeutic intervention to halt the progression of the illness.
Quidel Corporation discovers, develops, manufactures and markets rapid immunodiagnostic products for point-of-care detection of human medical conditions and illnesses. These products provide simple, accurate and cost- effective diagnoses for acute and chronic conditions in the areas of women's health and infectious diseases. QUIDEL's products are sold to professionals in the physician's office and clinical laboratories, and to consumers through store brand private labeling organizations. QUIDEL is based in San Diego, California. For more information on QUIDEL, visit http://www.quidel.com.
This press release contains forward-looking statements regarding QUIDEL and its future sales-related activities. Actual results could differ materially from those described or implied in this press release as a result of a number of factors, including, but not limited to, the future growth of the waived-only markets, any adverse actions by the Company's distribution partners, competitive products, other economic factors affecting the Company's markets, the degree of acceptance that new products achieve, and seasonality, as certain of these items have been discussed in the Company's annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. For more information on QUIDEL, visit http://www.quidel.com
Charles J. Cashion, Chief Financial Officer, 619-552-7962,
or Christa Cerciello, Investor Relations, 619-646-8031,
both of Quidel Corporation