Trinity Biotech Receives FDA Clearance for the Macra(R) Lp(a) for use on Automated Systems
DUBLIN, Ireland, Jan. 20 /PRNewswire/ -- Trinity Biotech plc (Nasdaq: TRIBY) today announced that it has received Food and Drug
Administration (FDA) marketing clearance for the Macra(R) Lp(a) assay for use on automated systems. The Macra(R) Lp(a) assay is a
microtitre plate assay used to measure the lipoprotein (a) contained in human serum. The test is distributed in the United States through
Wampole Laboratories, a division of New York City based Carter-Wallace, Inc. (NYSE: CAR).
Recent studies have identified Lp(a) as a significant risk factor for the development of coronary heart disease (CHD). Excess Lp(a) has
been associated with premature myocardial infarction and death among individuals with a family history of heart disease. The Macra(R)
Lp(a) assay is the only method cleared by the FDA for both diagnosis and risk assessment of CHD and it is now cleared for use on
automated systems. Prior to this clearance, Macra(R) was approved for manual use and was distributed through Wampole. The automated
systems market is considerably larger than the manual tests market, and this clearance improves the selling opportunities for the test.
Cardiovascular diseases (CVD) are the leading causes of death in the United States. Even for women, CVD cause many more deaths than
all cancers combined, including breast cancer. 58 million Americans have one or more types of CVD, including 14 million with CHD. At
least 250,000 people a year die of CHD within one hour of the onset of symptoms and before they reach the hospital. Lp(a) studies have
been described as "Powerful Predictors of Premature CHD in Selected Populations" and is the same test used in the renowned
Framingham Offspring Study.
"Trinity recognises the important role that automated systems play for the future of microtitre plate assays" commented, Ronan O'Caoimh,
Trinity Biotech's Chairman and CEO. "We feel it is important to ensure that our assays are certified for a variety of laboratory settings,
whether a small manual laboratory or a large, fully automated laboratory. The market for automated systems is expected to continue to
grow rapidly over the next several years. Trinity is committed to being a part of that growth opportunity by ensuring that our assays are
adapted for use on these automated systems."
Trinity Biotech acquired the Macra(R) Lp(a) assay in 1998 from Strategic Diagnostics, Inc. (Nasdaq: SDIX).
Trinity Biotech develops, manufactures, and markets over 100 diagnostic products for the point-of-care, self-testing, and clinical laboratory
segments of the diagnostic market. Trinity sells world-wide in over 80 countries through over 280 international distributors and strategic
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 commercialisation and technological difficulties, and other risks detailed
in the Company's periodic reports filed with the Securities and Exchange Commission.