Trinity Biotech Receives FDA Approval for Uni-Gold Recombigen® HIV Test use With Fingerstick Wholeblood


DUBLIN, Ireland -- Trinity Biotech plc announced it has received approval from the U.S. Food & Drug Administration (FDA) for the use of its Uni-Gold Recombigen® HIV Test with finger stick 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 percent sensitive and 99.7 percent 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 United States, African and Asian markets and has sold approximately $6 million of these products in the first three quarters of 2004.

Commenting on the FDA approval, Ronan OCaoimh, CEO, said While we were extremely pleased last year to get serum, plasma and whole blood approval for Uni-Gold HIV, todays finger stick whole blood approval is of significantly greater importance as it opens up for Trinity a much larger public health market including CDC funded programs. In addition, this finger-stick approval provides full access to a new doctors 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 U.S. market. This includes hospitals, reference laboratories, physicians offices, STD clinics and community-based organizations. We will continue to sell Uni-Gold HIV to hospitals, and public health sites through our established sales force of over 85 industry professionals and will market to the physicians office segment through appropriate distribution channels.

Uni-Gold Recombigen® HIV Test continues to enjoy competitive advantages particularly 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 programs such as PEPFAR (Presidents Emergency Program for AIDS Relief) and the WHO 3x5 program, 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 more than 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 more than 80 countries through its own sales force and a network of international distributors and strategic partners.

SOURCE: Trinity Biotech plc

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