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NABI SEEKS TO MARKET THIRD VIROCHEQC DIAGNOSTIC PRODUCT; VIROCHEQC I SERVES AS MULTI-CONSTITUENT CONTROL FOR HIV 1&2 AND HEPATITIS MARKERS

NABI SEEKS TO MARKET THIRD VIROCHEQC DIAGNOSTIC PRODUCT; VIROCHEQC I SERVES AS MULTI-CONSTITUENT CONTROL FOR HIV 1&2 AND HEPATITIS MARKERS
 MIAMI, June 24 /PRNewswire/ -- North American Biologicals, Inc. (NASDAQ: NBIO) ("NABI") today announced it has filed a 510(k) application for FDA clearance to market its VirocheQC(tm) I Quality Assurance Reagent, for use as an external control to promote the reliability of HIV 1 & 2, Hepatitis B antigen, Hepatitis core Ab, Hepatitis C Ab, and HTLV-I testing of the blood supply and blood products.
 "Our filing for FDA clearance of VirocheQC I exemplifies the continued expansion of our line of proprietary diagnostic products," commented David J. Gury, president of NABI. "NABI is already positioned as a leading provider of Quality Assurance Reagents for infectious diseases, and we look toward VirocheQC I, as a major new addition to our product line," Gury added.
 In March 1992 NABI received FDA clearance of QC-Hepatitis(tm): the first multi-level, multi-constituent reagent cleared by FDA to be used as an external control to promote the accuracy of hepatitis testing of the blood supply and blood supply products. NABI's first VirocheQC product, QC-HIV(tm), received FDA clearance in November 1991, and is the first multi-level HIV antibody reagent cleared by the FDA that is used as an independent control reagent for HIV testing. NABI is now marketing both QC-Hepatitis and QC-HIV products to reference laboratories, blood bank laboratories, and diagnostic product companies.
 The market for VirocheQC I Quality Assurance Reagents is estimated at approximately $25 million annually in the United States.
 Last month, NABI management participated in an FDA Blood Product Advisory Committee meeting to assist in industry preparation for CLIA '88 -- the Clinical Laboratories' Improvement Act of 1988 -- which requires the use of independent external controls to promote quality in infectious disease testing. The legislation becomes effective Sept. 1, 1992. In addition, the market is expected to grow in coming years due to increasing disease incidence and to the recently instituted regulatory requirements in both the U.S. and Europe mandating testing for additional strains of hepatitis in blood and plasma.
 "Our experience as one of the world's largest testing laboratories, and as a manufacturer of Quality Assurance Reagents, gives us a unique opportunity to address needs within the testing industry," said Dr. Raj Kumar, NABI's senior vice president. "We look forward to the opportunity of making VirocheQC I available to blood banks, other laboratories and organization conducting infectious disease testing."
 North American Biologicals, Inc., headquartered in Miami, Fla., is the world's largest independent provider of human blood plasma elements to the health care industry, a major AIDS screening laboratory, and a leading supplier of control products used to promote accuracy in blood testing laboratories.
 -0- 6/24/92
 /CONTACT: David J. Gury of NABI, 305-628-0080, or Lori Martin of Feinstein Partners Inc., 617-577-8110, for NABI/
 (NBIO) CO: North American Biologicals, Inc. ST: Florida IN: MTC SU: PDT


TM -- NE010 -- 3283 06/24/92 12:11 EDT
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Publication:PR Newswire
Date:Jun 24, 1992
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