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Tuesday July 21, 12:28 pm Eastern Time

Company Press Release

Trinity Biotech Files 510k With FDA for One Step Uni-Gold Strep A Test

DUBLIN, Ireland--(BW HealthWire)--July 21, 1998--Trinity Biotech plc (NASDAQ:TRIBY) today announced that it has submitted its Uni-Gold(tm) Strep A rapid test to the Food and Drug Administration (FDA) for marketing clearance.

The Company submitted a 510 (k) application to the FDA for clearance to market its rapid Uni-Gold Strep A test to clinical sectors in the United States. Extensive clinical trials demonstrated strong correlation of results between the Uni-Gold Strep A and laboratory tests. Trinity expects that its Uni-Gold Strep A test will be available for the 1998 Strep A testing season which commences in October.

Uni-Gold Strep A is a rapid, five minute test that will be performed at doctor's offices to differentiate between patients who have a bacterial streptococci throat infection and those with a viral infection. If the result is positive, the physician will then prescribe an antibiotic treatment to the patient. A negative result indicates a viral infection and thus no antibiotics will be required.

The current market for this test in the United States alone is estimated at $100 million per annum. Trinity reported that it is currently in discussions with a number of companies to establish solid marketing and distribution channels for the Uni-Gold Strep A.

Ronan O'Caoimh, chief executive officer of Trinity, stated, ``The launch will expand the Uni-Gold product line to six commercially available tests, two of which are cleared by the FDA while the Uni-Gold HIV and Strep A tests are now being reviewed by the FDA. The advent of an FDA-cleared Uni-Gold Strep A test will significantly increase Trinity's market presence in the U.S. rapid diagnostic market.''

Trinity Biotech develops, manufactures, and markets over 100 diagnostic products for the point-of-care (POC), self testing (OTC), and clinical laboratory segments of the diagnostic market. Trinity sells worldwide in over 75 countries through 130 international distributors and strategic partners, including Warner Lambert, Carter Wallace, and SmithKline Beecham.

Forward-looking statements in this release are made pursuant to the ``safe harbor'' provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such forward-looking statements involve risks and uncertainties, including but not limited to, the results of research and development efforts, the effect of regulation by the United States Food and Drug Administration and other agencies, the impact of competitive products, product development commercialization and technological difficulties, and other risks detailed in the Company's periodic reports filed with the Securities and Exchange Commission.


Contact:

     Trinity Biotech plc        OTC Communications
     Jonathan O'Connell         Robert M. Joyce
     800-603-8076               888-32-TRIBY (87429) ext. 11
     www.trinitybiotech.com     www.otcfn.com/triby

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