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CE Marking of Trinity Biotech's Rapid Test for Giardia

Trinity Biotech plc has obtained CE Marking and has filed for FDA approval for its new point-of-care Uni-Gold™ Giardia Test.The Trinity Biotech Uni-Gold™ 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 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.'

 


     
Tags: Clostridium difficile, Giardia, FDA, Cryptosporidium, Giardia lamblia

Date Published: February 28, 2012

Source article link: Trinity Biotech » company contact details
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