To: Keiko who wrote (8108 ) 2/18/1998 9:08:00 AM From: Findit Read Replies (1) | Respond to of 14328
Keiko and all some News - ÿÿ DUBLIN, Ireland--(BW HealthWire)--February 18, 1998--TRINITY BIOTECH PLC (Nasdaq: TRIBY) today announced the launch of its Uni-Gold(TM) one-step H. pylori test.ÿ Using one drop of whole blood, serum or plasma the test screens for the presence of antibodies to the bacterium Helicobacter pylori.ÿ Helicobacter pylori is believed to be the causative agent in over 90% of duodenal ulcers, 70% of gastric ulcers and 60% of gastric cancers and is recognized worldwide as the leading cause of peptic ulcer disease and has recently been classified by the WHO as a definitive carcinogen for gastric cancer. Estimates from the Centers for Disease Control and Prevention indicated that 25 million Americans have had a peptic ulcer during their lifetime and international infection rates can exceed 80% especially in Asia and Latin America.ÿ ÿÿ Trinity Biotech's Uni-Gold(TM) H. pylori test facilitates the rapid assessment of patients presenting with the symptoms of gastric or duodenal ulcers.ÿ It is a quick, efficient and inexpensive alternative to endoscopy, which is invasive and requires a specialist to administer.ÿ The test is simple to perform and is extremely cost effective in that it will enable physicians at the point of care not only to diagnose H. pylori infection but also to initiate therapy.ÿ ÿÿ Uni-Gold(TM) H. pylori adds to Trinity's increasing range of one-step tests for the point-of-care (POC) and self-test (OTC) markets.ÿ The Uni-Gold(TM) product range includes tests for hCG, HIV and Hepatitis B with tests for Strep A and Chlamydia to be released later in 1998.ÿ ÿÿ Commenting on the announcement, Mr. Ronan O'Caoimh, CEO at Trinity Biotech said, "We are delighted to launch our Uni-Gold(TM) H. pylori test which has demonstrated very accurate results in multi-center trials.ÿ Initial shipments of Uni-Gold(TM) H. pylori have already commenced in Europe and we are currently preparing a submission for the FDA for marketing approval.ÿ FDA approval will then enable Trinity to access the growing US market in which over 25 million Americans annually suffer from H. pylori infection".ÿ ÿÿ Trinity Biotech develops, manufactures and markets diagnostic products which address all three segments of the diagnostic market, (1) rapid tests for the emerging point of care (POC) market, (2) simplified tests for the self test (OTC) market and (3) microtitire plate kits for the clinical laboratory market.ÿ ÿÿ The company's products are sold in over 65 countries around the world.ÿ -0-ÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿ "Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995.ÿ 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. ÿÿ --30--cf/ny* ÿÿ CONTACT:ÿ Trinity Biotech Plc ÿÿÿÿÿÿÿÿÿÿÿÿ Jonathan O'Connell ÿÿÿÿÿÿÿÿÿÿÿÿÿ Chief Financial Officer ÿÿÿÿÿÿÿÿÿÿÿÿÿ (800) 603-8076 ÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿ or ÿÿÿÿÿÿÿÿÿÿÿÿÿ Olga M. Fleming ÿÿÿÿÿÿÿÿÿÿÿÿÿ olga@lhai.com ÿÿÿÿÿÿÿÿÿÿÿÿÿ Lippert/HeilshornAssociates, Inc. ÿÿÿÿÿÿÿÿÿÿÿÿÿ (212) 838-3777