Trinity Biotech Receives FDA Clearance of Two Additional Infectious Disease Markers
Business Wire - August 05, 1998 10:31
DUBLIN, Ireland--(BW HealthWire)--Aug. 5, 1998--Trinity Biotech plc (NASDAQ:TRIBY) today announced that it has received Food and Drug
Administration (FDA) marketing clearance of two additional markers that detect the presence of the Epstein Barr Virus (EBV). The products will be
distributed in the United States through Wampole Laboratories, a division of Carter Wallace, Inc. (NYSE:CAR).
These two EBV assays, VCA P18 IgG and VCA IgM, complete the entire panel of EBV markers offered by Trinity Biotech. EBV markers detect the
presence of antibodies and identify the stage of disease progression. By running all five EBV markers simultaneously, physicians are now able to
more accurately determine the various stages of infectious mononucleosis. EBV has also been linked to several types of cancers, including Burkitt's
lymphoma and nasopharyngeal carcinoma.
The VCA P18 IgG and VCA IgM markers incorporate technologies using a recombinant antigen and an affinity purified antigen, respectively, which
provide better sensitivity when compared to traditional antigen propagation methods. These assays utilize a format easily adaptable to automated
systems.
Ronan O'Caoimh, chief executive officer of Trinity, said, "The release of the additional EBV assays confirms Trinity's commitment to providing a
complete line of microtitre plate EIA products. Through our on-going research and development efforts, we intend to continue providing our
customers with the latest technology available while also focusing on growing market trends towards automation."
Epstein Barr Virus, which causes infectious mononucleosis (mono) and has been linked to Burkitt's lymphoma and nasopharyngeal carcinoma, is
contracted by an estimated 80% of Americans at some point over the course of their lifetime. The virus infects 90% of the worldwide population.
Trinity Biotech develops, manufactures, and markets over 100 diagnostic products for the point-of-care (POC), self testing (OTC), and clinical
laboratory segments of the diagnostic market. Trinity sells worldwide in over 75 countries through 130 international distributors and strategic partners,
including Warner Lambert, Carter Wallace, and SmithKline Beecham.
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.
CONTACT: Trinity Biotech plc OTC Communications
Jonathan O'Connell Robert M. Joyce
800-603-8076 888-32-TRIBY (87429) ext. 11
www.trinitybiotech.com www.otcfn.com/triby |
