To: Zakattack who wrote (776 ) 6/1/1998 9:55:00 AM From: Don Powrie Read Replies (1) | Respond to of 8798
>>>>NEWS! NASDAQ:TRIBY Company Press Release Trinity Biotech Receives FDA Clearance of Two Infectious Disease Markers DUBLIN, Ireland--(BW HealthWire)--June 1, 1998--Trinity Biotech plc (NASDAQ:TRIBY - news) today announced that it has received FDA marketing clearance of two new markers that detect the presence of the Epstein Barr Virus (EBV), the cause of mono and chronic fatigue syndrome. The products will be distributed in the U.S. through Wampole Laboratories, a division of Carter-Wallace, Inc. (NYSE:CAR - news). Ronan O'Caoimh, chief executive officer of Trinity, said, ''The recent FDA clearance of EBV markers represents our continued commitment to providing a diverse and extensive line of diagnostic products. We already have over 80 FDA approved test kits and are dedicated to further expanding our product line.'' Trinity is rapidly emerging as an enzyme immunoassay (EIA) market leader with more than 84 products aimed at this segment. The Company's EBV markers, which are EIAs in microtitre plate format, will be sold to the clinical lab sector of the diagnostic market through an agreement with Wampole Laboratories. In addition to the EBV markers, Wampole distributes other Trinity products throughout the U.S. EBV causes infectious mononucleosis (mono) and has been linked to several types of cancer, including Burkitt's lymphoma and nasopharyngeal carcinoma. It is classified as a member of the herpesvirus family and is contracted by 95% of Americans, 50% of whom develop mono symptoms. 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. The EBNA-1 IgM marker detects early development while the EA-D IgG detects the acute progression of the virus. Trinity Biotech develops, manufactures, and markets over 90 diagnostic products for the point-of-care (POC), self testing (OTC), and clinical laboratory segments of the diagnostic market. The Company's diagnostic tests detect infectious diseases and autoimmune disorders such as HIV, rubella, herpes simplex, measles, adenovirus, rotavirus, and rheumatoid arthritis. Trinity sells worldwide in over 65 countries through 110 international distributors and strategic partners including Warner Lambert, Carter Wallace, SmithKline Beecham, and Bayer Diagnostic. -0- Forward-looking statements in this release are made pursuant to the ''safe harbor'' provisions 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 commercialization and technological difficulties, and other risks detailed in the Company's periodic reports filed with the Securities and Exchange Commission.