Trinity Biotech plc (TRIB) said it had obtained CE Marking and has filed for FDA approval for its new point-of-care Uni-GoldTM Giardia Test. Giardiasis is caused by an enteric parasite, Giardia lamblia, that infects the colon of humans and animals. The Trinity Biotech Uni-GoldTM Giardia Test has been designed as a rapid lateral flow immunoassay to detect the presence of Giardia lamblia antigen in fresh and preserved human stool specimens.
Also, Trinity Biotech added that CE marking allows this product to be sold in European markets and the company would immediately begin selling this product via. its extensive distributor network in Europe and other territories. In the mean time, the company has 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'sSan Diego facility and is the first of a new range of point-of-care tests to be developed. When this product is combined with its forthcoming tests for Cryptosporidium and C Difficile, Trinity would then have a full enteric panel, all of which would be CE marked by June 2012 and approved for sale in the USA by the third quarter end.
by RTT Staff Writer
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