FDA CLEARS NABI'S QC-HIV FOR MARKETING
FDA CLEARS NABI'S QC-HIV FOR MARKETING MIAMI, Nov. 25 /PRNewswire/ -- North American Biologicals, Inc.
("NABI") (NASDAQ: NBIO) today announced that its QC-HIV(tm) Quality Assurance Reagent for in vitro diagnostic use has been cleared for commercial distribution by the Food and Drug Administration. QC-HIV is the first multilevel HIV antibody reagent cleared by the FDA that is used as an external control for HIV testing. NABI will begin marketing the product immediately to reference laboratories, blood bank laboratories, and diagnostic product companies.
"We believe that AIDS testing will increase in coming months as a result of Magic Johnson's recent announcement of testing HIV positive. NABI's launch of QC-HIV is therefore particularly timely, since we anticipate a growing need for such a product to ensure the accuracy of AIDS tests on a large scale," said NABI President David J. Gury. "We also view QC-HIV as another significant addition to our portfolio of proprietary products derived from plasma. NABI has extensive expertise in the development of such testing reagents, and we continue to strengthen our position as a leading provider of Quality Assurance Reagents for infectious diseases," Gury added. The market for HIV Quality Assurance Reagents is estimated at $5 million-$10 million annually in the United States. The market is expected to grow in coming years due to increased volume of testing, and the Clinical Laboratory Improvement Act of 1988 that will soon make it necessary for laboratories to use independent external controls to ensure the quality of HIV testing. QC-HIV offers numerous advantages to laboratories. It is derived from human plasma and is, therefore, most like the human specimens undergoing HIV testing. QC-HIV and its companion products, SERO-HIV(tm) and CHALLENGE-HIV(tm), together provide a comprehensive approach through which a laboratory can meet all its HIV quality testing needs. These products are included as part of NABI's VirocheQC(tm) line. North American Biologicals, Inc. is the world's largest independent provider of human blood plasma elements to the health care industry. The company collects, processes, tests and distributes human-blood- related products, manufactures and markets plasma/sera-based diagnostic products and markets clinical diagnostic testing services. QC-HIV is part of the company's ongoing program of developing and manufacturing human-serum-based products to assure accurate testing for infectious diseases. -0- 11/25/91 /CONTACT: David J. Gury, president of North American Biologicals, 305-628-0800, or Marcia A. Kean of Feinstein Partners, 617-577-8110, for North American Biologicals/ (NBIO) CO: North American Biologicals, Inc. ST: Florida IN: MTC SU: PDT
KM-SH -- NE003 -- 6853 11/25/91 12:37 EST
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|Date:||Nov 25, 1991|
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