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Trinity Biotech: Trinity Biotech Announces TRI-stat(TM) CLIA Submission to FDA

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^{Published in Health and Fitness on Monday, July 20th 2009 at 5:43 GMT, Last Modified on 2009-07-20 05:43:39 by Market Wire}  

DUBLIN, IRELAND--(Marketwire - July 20, 2009) - Trinity Biotech plc (NASDAQ: [ TRIB ]), a leading developer and manufacturer of diagnostic products for the point-of-care and clinical laboratory markets, today announced it has submitted its CLIA application for its TRI-stat™ point-of-care HbA1c product to the FDA.

TRI-stat™ is designed to measure HbA1c, also known as glycated hemoglobin, a measure of a patient's average blood sugar control over the last two to three months. The availability of TRI-stat™ will improve overall efficiency of diabetes care by delivering HbA1c values during the patient's visit to the doctor's office. Utilizing a patented boronate affinity and two-phase optical system, together with a simple, fully automated, plug-and-play instrument design, TRI-stat™ offers highly accurate results in minutes while eliminating the need for refrigeration found with the other three competing products.

Diabetes is the fourth leading cause of death by disease in the world. According to the International Diabetes Federation, the number of people diagnosed with type 2 diabetes worldwide has increased from 30 million to more than 246 million over the last two decades. This figure is projected to increase further to 380 million by 2025. In the U.S., some 20.8 million Americans (7 percent of the population) have the disease with a further 54 million Americans considered to be pre-diabetic. The test will allow Trinity to address a doctors' office global market of approximately $200 million.

Commenting on the news, Ronan O'Caoimh, CEO, said, "Following the successful completion of our CLIA trials in four independent sites in the USA, I am delighted to announce the submission of our TRI-stat™ CLIA application to the FDA. The test will allow us to address a market which continues to grow significantly each year due to the need for decentralisation of testing to doctors' offices, the recommendations from the American Diabetes Association and the International Diabetes Federation for more frequent patient monitoring and the ongoing increase in the prevalence of diabetes. We will be showcasing the product at the AACC Clinical Lab Expo in Chicago on 21-23 July, 2009."

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.

Trinity Biotech develops, acquires, manufactures and markets diagnostic systems, including both reagents and instrumentation, for the point-of-care and clinical laboratory segments of the diagnostic market. The products are used to detect infectious diseases and blood coagulation disorders, and to quantify the level of Haemoglobin A1c and other chemistry parameters in serum, plasma and whole blood. Trinity Biotech sells direct in the United States, Germany, France and the U.K. and through a network of international distributors and strategic partners in over 75 countries worldwide. For further information please see the Company's website: [ www.trinitybiotech.com ].