| Back to Press Releases Monday June 1, 11:04 am Eastern Time Trinity Biotech says FDA clears product
NEW YORK, June 1 (Reuters) - Ireland-based Trinity Biotech Plc said Monday it has received Food and Drug Administration marketing clearance of two new markers that detect the presence of the Epstein Barr Virus, the cause of mononucleosis and chronic fatigue syndrome. The products will be distributed in the United States through Carter-Wallace Inc.'s (CAR - news) Wampole Laboratories. In addition to detecting virus antibodies, markers identify the stage of disease development, thus enabling physicians to monitor disease progression and administer the appropriate treatment, Trinity said. ``The recent FDA clearance of EBV markers represents our continued commitment to providing a diverse and extensive line of diagnostic products,'' Ronan O'Caoimh, chief executive officer of Trinity, said in a statement. ``We already have over 80 FDA approved test kits and are dedicated to further expanding our product line.'' The Epstein Barr Virus causes infectious mononucleosis (mono) and has been linked to several types of cancer, including Burkitt's lymphoma and nasopharyngeal carcinoma, the company said. It is classified as a member of the herpesvirus family and is contracted by 95 percent of Americans, 50 percent of whom develop mono symptoms, the company said. |