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DISEASE DETECTION INTERNATIONAL TO COMMENCE U.S.A. CLINICAL TRIALS OF SEVEN-MINUTE, SEROCARD(R) HIV-1, AIDS TEST UNDER FDA 'IND' SUBMISSION

DISEASE DETECTION INTERNATIONAL TO COMMENCE U.S.A. CLINICAL TRIALS OF SEVEN-MINUTE, SEROCARD(R) HIV-1, AIDS TEST UNDER FDA 'IND' SUBMISSION
 IRVINE, Calif, Nov. 10 /PRNewswire/ -- Disease Detection International Inc. ("DDI") (OTC Bulletin Board: DDII) announced today that the company will commence formal clinical studies of its SeroCard(R) HIV-1, seven-minute AIDS test under its United States Food and Drug Administration (FDA) Investigational New Drug ("IND") application. DDI's president and chief executive officer, H. Thad Morris, stated that the company's IND application seeking approval to commence formal clinical trials has received its Center for Biologics Evaluation and Research (CBER) product name and identification number related to the submission. While the center does not endorse the test or the application, formal clinical studies may not commence until 30 days after receipt of the application, which have elapsed. The company previously announced its submission and has not received verbal or written objections to the clinical trial protocols.
 Morris indicated the formal clinical studies and FDA submissions are being conducted by Schiff & Co. of West Caldwell, N.J., a consulting firm specializing in pharmaceutical and diagnostic regulatory affairs. Robert Schiff, Ph.D., president of Schiff & Co., stated the clinical testing will require three-five months in various testing centers identified in the company's submission.
 The SeroCard HIV-1 rapid test to detect the presence of antibodies to the AIDS virus has received the scientific and regulatory approval in Thailand, Mexico and Sweden as previously reported. In those international studies, the seven-minute test was approved using serum, plasma or whole blood from a simple finger stick to obtain a test specimen. Those international studies indicated the SeroCard HIV-1 test to have a sensitivity of 99.7 percent and specificity of 99.8 percent.
 Morris further elaborated that the patented SeroCard(R) device has been exclusively licensed to Trinity Biotech plc (NASDAQ: HIVUF, HIVSY) an Ireland-based, international biotechnology firm. Trinity has used the SeroCard technology to develop a rapid AIDS test using saliva as a test sample and will market both testing formats outside the United States and Canada. In a recently announced financing and licensing agreement with Trinity Biotech, DDI received $1 million in exchange for granting the exclusive rights to the SeroCard patent to Trinity Biotech, to be used to develop a family of rapid tests for infectious and sexually transmitted diseases which can use saliva as a test sample. As part of the agreements and other financial considerations, Trinity Biotech has purchased a 70+ percent interest in DDI. In a stock exchange, DDI has received 600,000 shares of Trinity's common stock (HIVSY) and exclusive marketing rights in the United States and Canada for both SeroCard HIV-1 tests.
 Morris also stated, "We are very pleased on behalf of our shareholders to financially support this FDA submission for our test, which we believe, can have a positive impact on global testing for exposure to the AIDS virus. While DDI and Trinity plan to move quickly for approval of the SeroCard HIV-1, rapid saliva and blood tests in virtually all countries of the world, commencing with India and Italy; the United States approval process may take one year or longer."
 -0- 11/10/92
 /CONTACT: H. Thad Morris, president and CEO of Disease Detection International, 714-457-1787/
 (HIVUF HIVSY) CO: Disease Detection International Inc.; Trinity Biotech plc ST: California IN: MTC SU: PDT


KJ-JB -- LA027 -- 9403 11/10/92 15:42 EST
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Publication:PR Newswire
Date:Nov 10, 1992
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