Is this significant enough to move the price?
DUBLIN, IRELAND--(BUSINESS WIRE)--Jan. 7, 1997--TRINITY BIOTECH plc (NASDAQ:TRIBY) today announced it has received FDA clearance to market its Adenovirus test kit. The test is an enzyme immunoassay (EIA) in microtitre plate format, which detects the presence of the Adenovirus in stool samples. The Trinity EIA kit uses a combination of antibodies to directly test for the virus and greatly reduces the time required by traditional cell culture isolation. The product will be distributed in the U.S. by Wampole Laboratories, a division of Carter Wallace, Inc. (NYSE:CAR).
Ronan O'Caoimh, Chief Executive Officer of Trinity Biotech,
stated, "Approval of the Adenovirus test kit adds to Trinity's
expanding product offering in the gastrointestinal disease market.
Trinity currently sells two other FDA approved kits to the U.S.
market and is developing tests for Cryptosporidium, Giardia and E. Histolytica. Trinity also has a C. difficile kit currently being
marketed in Europe and plans to file an FDA submission during the
first quarter 1998."
Adenoviruses are responsible for a wide variety of clinical
illnesses ranging from gastroenteritis and upper respiratory diseases
in children to large outbreaks of pneumitis in military recruits.
Infectious gastroenteritis, of which Adenovirus is considered the
second leading cause, affects more than 210,000 children in the U.S.
annually and causes between 4-10 million deaths in children
worldwide.
Trinity Biotech develops, manufactures and markets over 90
diagnostic tests which address all three segments of the diagnostic
market 1) test kits for the clinical laboratory or traditional
market; 2) rapid tests for the emerging point-of-care (POC) market
and 3) simplified tests for the over-the-counter (OTC) market. The
company's tests are sold around the world in 65 countries.
"Safe Harbor" Statement under the Private Securities Litigation
Reform Act of 1995. The statements which are not historical facts
contained in this release are forward-looking statements that 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 (FDA) and other agencies,
the impact of competitive products, product development,
commercialization and technological difficulties, and other risks
detailed in the Company's Securities and Exchange Commission filings.
CONTACT: Jonathan O'Connell
Chief Financial Officer
800/603-8076
or
INVESTOR RELATIONS CONTACT:
Bruce Voss, bruce@lhai.com |
