Trinity Biotech Announces CE Marking of Rapid Test for Giardia
Giardiasis is caused by an enteric parasite, Giardia lamblia, that infects the colon of humans and animals and is one of the most common waterborne diseases in the world. Infection typically occurs by consuming contaminated food and water containing the Giardia cyst. Giardiasis occurs most often in children and is common in day care centers. Chronic infections of months to years can occur and can contribute to decreased lifespan in immuno-deficient persons.
The Trinity Biotech Uni-GoldTM Giardia Test has been designed as a rapid (15 minutes) lateral flow immunoassay to detect the presence of Giardia lamblia antigen in fresh and preserved human stool specimens. CE marking allows this product to be sold in European markets and we will immediately commence selling this product through our extensive distributor network in Europe and other territories. Meanwhile, the Company has also filed for FDA approval in the USA and this is expected to be granted in the first half of 2012.
The product was developed by a dedicated research team at Trinity's San Diego facility and is the first of a new range of point-of-care tests to be successfully developed. When this product is combined with our forthcoming tests for Cryptosporidium and C Difficile, Trinity will then have a full enteric panel, all of which will be CE marked by June 2012 and approved for sale in the USA by the end of quarter 3, 2012.
Commenting on the announcement, Trinity Biotech's CEO Mr. Ronan O'Caoimh said, "We are delighted to announce the CE marking of our new Uni-GoldTM Giardia Test. The product has also been submitted for FDA approval, which we expect to receive in the coming months. In mid-2010, we announced that Trinity was embarking upon an ambitious program to develop a new range of rapid point-of-care products. This is the first of these new products to be launched. Development of the other products in the range at our San Diego facility is progressing very well. Cryptosporidium and C Difficile, which will complete our enteric panel, will be launched by June 2012 and these will be joined by new syphilis, strep pneumonia and HSV products by the end of the year."
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 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.
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Contact:
Trinity Biotech plcKevin Tansley(353)-1-2769800E-mail: kevin.tansley@trinitybiotech.comLytham Partners LLCJoe Diaz, Joe Dorame & Robert Blum602-889-9700