CE Marking Announced for Trinity Biotechs Rapid Giardia Test

Trinity Biotech has announced that is has obtained CE Marking for its new point-of-care Uni-Gold^TM Giardia Test. The company has also filed for U.S. Food and Drug Administration (FDA) approval for the product.

Giardiasis is caused by Giardia lamblia, an enteric parasite which infects the colon of humans and animals and is one of the most common waterborne diseases in the world. Infection is usually transmitted by consuming contaminated food and water containing the Giardia cyst. The infection is most common in children and is common in day care centers. Chronic infections lasting from months to years can occur and can contribute to decreased lifespan in immune-deficient patients.

The Trinity Biotech Uni-Gold^TM Giardia Test is a rapid lateral flow immunoassay which takes only 15 minutes to produce a result. The assay detects the presence of Giardia lamblia antigen in fresh and preserved human stool specimens.

The CE marking will allow this product to be sold in European markets and Trinity Biotech will commence selling the product immediately through their extensive distributor network. The FDA approval 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. Trinity Biotech intends to complement this test with forthcoming assays for Cryptosporidium and C Difficile, which will make up a full enteric panel.

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.”