Important note: Information in this article was accurate in 2004. The state of the art may have changed since the publication date.
PRNewswire - November 10, 2004
Trinity Biotech's Uni-Gold(TM) Recombigen(R) HIV test is approved by the FDA for the detection of antibodies to HIV in human serum, plasma, venous and finger stick whole blood and is the only Rapid HIV Test to be approved for use with all four sample types. The product is easy to use, requires one-step and produces a result within ten minutes. The test is highly accurate being 100% sensitive and 99.7% specific.
The FDA has now approved a waiver for Trinity's Uni-Gold(TM) HIV test when used with venous and finger stick whole blood. The significance of this waiver is that the test can be used by almost 200,000 test sites including physician's offices and clinics in addition to its previously approved applicability in the hospital environment. CLIA waiver is necessary to address the public health market segment which is estimated to be three times the size of the hospital laboratory market. Currently only one other rapid HIV test competes in this market segment and Trinity's Uni-Gold(TM) product has the advantages of being twice as fast and more accurate than its competitor.
"With the receipt of the CLIA waiver for use of Uni-Gold(TM) HIV with finger stick whole blood, we have now completed the final regulatory hurdle for our product" said Ronan O'Caoimh, CEO of Trinity Biotech. "Trinity set out to develop a test which would be approved by the FDA for sale in the United States utilizing serum, plasma, venous and finger stick whole blood as samples and this we have achieved. We are proud to have reached this milestone in Trinity's development and I wish to take this opportunity to thank all of the Trinity staff who helped to make this possible. During 2004 our 90 strong sales & marketing team in the United States launched Uni-Gold(TM) HIV in the hospital market and with the finger stick approval and CLIA waiver, this group will now also turn its focus on to the significantly larger public health and physician's office market segments. We are excited at the prospect of what this means for Trinity Biotech's future growth and know that our successful experience of marketing the product in sub-Saharan Africa can be applied to the U.S. market".
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: http://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.
SOURCE Trinity Biotech plc
041110
PR041114
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