FDA APPROVES TRINITY'S UNI-GOLD RECOMBIGEN HIV TEST.

Trinity Biotech plc (NASDAQ: TRIB), Dublin, Ireland, has received approval from the U.S. Food and Drug Administration (FDA) to market its Uni-Gold Recombigentm HIV test in the United States.

The product is approved for the detection of antibodies to HIV in human serum, plasma or whole blood and is the first and only device to be approved for use with all three sample types. Uni-Gold Recombigentm HIV is simple to use, requiring only one step and produces a result within 10 minutes, whereas with conventional laboratory tests for HIV, results may not be available for hours or even days. Uni-Gold Recombigentm HIV was approved by the FDA on the basis of clinical trial results on over 9,000 patient specimens where the product demonstrated a test sensitivity of 100% and a specificity of over 99.7%.

Commenting on the FDA approval, Ronan O'Caoimh, CEO said: "We are delighted to receive FDA approval of our Uni-Gold HIV Test. Our decision to apply for approval to market the product utilizing three sample types is vindicated as we are now able to enter all market segments of significance in the US."

"Uni-Gold HIV has become the Gold Standard in the fight against Aids in Africa. Given this experience Trinity clearly has the production capability to meet the expected demand in the US for this product. We will market the product in the US using our own direct sales force. In anticipation of approval we have been building our US sales and marketing team and recently announced the hiring of Dr Philippe Gadal, previously head of Stago, to spearhead our efforts."

"Approximately. 800,000 needle stick injuries occur in US hospitals each year requiring an immediate serum/plasma HIV test. In addition approximately. 200,000 at risk pregnant women present at hospitals and require a rapid HIV test each year. The multi step SUDStm device serviced this $10m market until recently when the product was permanently withdrawn. In the meantime no product has been available to service this market because no rapid test with a serum or plasma claim had been approved. With immediate effect, through our direct sales force and through a tele-sales team Trinity is in a position to fill this gap and supply the market. Product is available through free phone [phone]."

"Rapid HIV Testing in doctor's offices throughout the US is a new market which, while difficult to quantify, will clearly be significant. Trinity is distributing Uni-Gold HIV to this market through a range of distributors."

Brendan Farrell, president, added, "Trinity's Uni-Gold Recombigentm HIV has enjoyed significant success in the fight against HIV infection in Africa where it is approved by the World Health Organization and used by the Centers for Disease control in their Voluntary Counselling and Testing Programs. With the $15 bn committed by President Bush to combat HIV/AIDS in Africa beginning to flow, Trinity, with its high profile in the African market and its proven production capability, is in an ideal position to assist in making the program a success."

"We believe that this success can be replicated in the USA where there is an incidence of 40,000 new HIV infections annually. Experience in CDC funded HIV programs has shown that up to 40% of those tested for HIV using conventional lab based tests will not return for their results. The rapid test allows for on-the-spot results that can increase the diagnosis of infected people. The conversion of these lab based HIV tests to rapid products represents an estimated annual market opportunity of 3 million tests or $30 million."

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 sales force and a network of international distributors and strategic partners.

For more information, visit http://www.trinitybiotech.com or call 646/536-7028.