Trinity Biotech Acquires Lp-a Assay for Diagnosis and Risk Assessment of Coronary Heart Disease.

DUBLIN, Ireland--(BUSINESS WIRE)--Sept. 24, 1998--Trinity Biotech plc (NASDAQ:TRIBY) today announced that it has entered into an agreement to acquire an assay that measures Lipoprotein Lp(a), a powerful predictor of premature atherosclerosis and coronary heart disease. The Lp(a) test, called Macra Lp(a), is the only Lp(a) method cleared by the FDA for both diagnosis and risk assessment of coronary heart disease.

Trinity entered into the agreement with Strategic Diagnostics, Inc. (NASDAQ:SDIX) of Newark, Delaware. The transaction includes both the ELISA assay and the antibody cell cultures for the manufacture of base antibody. Although financial terms of the agreement were not disclosed, the Company announced that the transaction did not involve the issuance of Trinity stock.

Trinity intends to sell Macra Lp(a) in the U.S. through its marketing partner, Wampole Laboratories, a division of Carter Wallace (NYSE:CAR). Strategic Diagnostics will continue to manufacture the Lp(a) assay until January 1999, at which time the manufacturing will transfer to Trinity. Macra Lp(a) generated revenues of approximately $350,000 in 1997, prior to its April 1998 FDA clearance.

Recent studies conducted by the Framingham Cohort, the Lipid Research Clinics Coronary Primary Prevention Trial, and other groups, have identified Lp(a) as a significant risk factor for the development of coronary heart disease. Excess Lp(a) has been identified as an important predictor for those who develop the disease prematurely or who have a family history of premature atherosclerosis. In addition, leading lipid experts are now recommending the test for the nearly one million people who require angioplasty or coronary bypass surgery.

"We are excited about the opportunity to expand our product menu to include cardiac markers," said Ronan O'Caoimh, CEO at Trinity. "This market is recognised as high growth, especially as cardiologists continue to focus on risk factors like Lp(a) for diagnosing coronary heart disease. With the FDA clearance for predictive use of this molecule, we believe that we can significantly grow the existing sales base in the U.S.A. and there are also excellent growth opportunities in the rest of the world where Strategic Diagnostics has no existing sales base. The Macra Lp(a) also fits well with Trinity's long term commitment to growing its ELISA product line."

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.