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TRINITY BIOTECH ANNOUNCES PRE-MARKET IND APPROVAL FROM FDA ON BLOOD- BASED RAPID AIDS DIAGNOSTIC TEST AND TRIALS OF SALIVA-BASED AIDS TEST

 GALWAY, Ireland, Dec. 21 /PRNewswire/ -- Trinity Biotech plc (NASDAQ: HIVSY) announced that its affiliate, Disease Detection International (DDI) of Irvine, Calif., has received approval from the FDA for the pre-market clinical trials (IND) of its blood-based rapid HIV antibody test. DDI has already received 510(K) FDA approval for seven different rapid diagnostic tests, employing the same patented device and similar technology, including those for toxoplasmosis, rubella, cyatomegalovirus and herpes (TORCH).
 Trinity also announced that it has agreed to protocols for clinical trials on saliva-based rapid HIV testing in Abu Dhabi, Thailand, Italy, South Africa and England. Shipments of test kits will commence from Ireland immediately after Christmas to the overseas test sites where the company believes the market is the largest for its stand alone, rapid saliva-based AIDS test. Moreover the data collected in these five trials is expected to be sufficient to allow an IND application to be filed with the FDA in the second quarter of 1993.
 Trinity expects that its data from its non-U.S. trials will provide answers to many of the concerns currently being expressed by the FDA with regard to saliva collection, test specificity, sensitivity and reproducibility.
 The date Trinity believes it has developed the only rapid, saliva- based diagnostic test in clinical trials. Importantly, the Trinity rapid HIV test has been engineered in a format that has already achieved approvals from the FDA and other regulatory bodies.
 Trinity Biotech plc is an Ireland-based diagnostics company dedicated to the development of rapid, on-site saliva tests for HIV and other sexually transmitted diseases.
 -0- 12/21/92
 /CONTACT: Michael Hubbard of Trinity, 503-227-0643, or Howard Bronson of Howard Bronson & Company, 212-867-6160, for Trinity/
 (HIVSY)


CO: Trinity Biotech plc ST: California IN: MTC SU: PDT

KD-TM -- NY064 -- 8944 12/21/92 17:46 EST
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Date:Dec 21, 1992
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