FOR RELEASE, SEPTEMBER 29, 2004 Company : Trinity Biotech plcIDA Business Park Southern Cross Road Bray, Co Wicklow Ireland Tel : (353)-1-2769800Contact : Brendan K. Farrellbrendan.farrell@trinitybiotech.com Trinity Biotech Receives FDA Approval For Uni-Gold™ Recombigen ® HIV Test usewith Fingerstick Wholeblood DUBLIN, Ireland (Wednesday, September 29, 2004)…. Trinity Biotech plc(NASDAQ: TRIB) today announced it has received approval from the US Food & Drug Administration (FDA) for the use of its Uni-Gold™ Recombigen ® HIV Test with fingerstick whole blood samples. The test, which gives results within 10 minutes, is now approved for the detection of antibodies to HIV in human serum, plasma, venous and finger stick whole blood and is the first and only device to be approved for use with all four sample types. A finger stick whole blood sample is normally a drop of blood taken from the finger or thumb with a lancet. This is the simplest and most rapid procedure for producing a sample for HIV testing. Uni-Gold™ Recombigen ® HIV is simple to use, provides rapid results and is 100%sensitive and 99.7% specific. The product has previously received CLIA waiver for use in detecting HIV 1 antibodies in venous whole blood samples and Trinity has already applied for CLIA waiver for finger stick whole blood. Trinity Biotech is a leading supplier of Rapid HIV tests in the US, African and Asian markets and has sold approximately $6million of these products in the first three quarters of 2004. Commenting on the FDA approval, Ronan O’Caoimh CEO said “While we were extremely pleased last year to get serum, plasma and whole blood approval for Uni- Gold™ HIV , today’s finger stick whole blood approval is of significantly greater importance as it opens up for Trinity a much larger public health market including CDC more-more-more -2- funded programmes. In addition, this finger stick approval provides full access to a new doctor’s office market for Trinity Biotech. We have already applied for CLIA waiver for the finger stick whole blood claim and confidently expect to receive it in the next month. This latest approval means that our Uni-Gold™ HIV test can now be used in all significant segments of the US market. This includes hospitals, reference laboratories, physician’s offices, STD clinics and community based organisations. We will continue to sell Uni-Gold™ HIV to hospitals, and public health sites through our established salesforce of over 85 industry professionals and will market to the physician’s office segment through appropriate distribution channels. Uni-Gold™ Recombigen ® HIV Test continues to enjoy competitive advantagesparticularly in the areas of speed to test result and sensitivity. These advantages are now further enhanced by the approval to use multiple sample types with our product. With the increase in worldwide funding to fight HIV/AIDS through programmes such as PEPFAR (President’s Emergency Programme for AIDS Relief) and the WHO 3x5 programme, there will be a significant increase in the use of rapid HIV tests over the coming years and Trinity Biotech is very well positioned to take advantage of this growth in the marketplace”. Trinity Biotech develops, acquires, manufactures and markets over 500 diagnostic products for the point-of-care and clinical laboratory segments of the diagnostic market. The broad line of test kits are used to detect infectious diseases, sexually transmitted diseases, blood coagulation disorders, and autoimmune diseases. Trinity Biotech sells worldwide in over 80 countries through its own salesforce and a network of international distributors and strategic partners. For further information please see the Company’s website: www.trinitybiotech.com.Forward-looking statements in this release are made pursuant to the "safe harbor" provision 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 commercialisation and technological difficulties, and other risks detailed in the Company's periodic reports filed with the Securities and Exchange Commission.
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