I know this was already posted, but no one seemed to notice - so here it is again. Any Feedback?
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.
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