Healthcare Industry News: Inverness Medical Innovations
News Release - June 21, 2007
Trinity Biotech Announces Launch of Uni-Gold(TM) Legionella Urinary Antigen TestDUBLIN, IRELAND--(Healthcare Sales & Marketing Network)--Jun 21, 2007 -- Trinity Biotech plc (NasdaqGS:TRIB ) (DUBLIN: TRIB), a leading developer and manufacturer of diagnostic products for the point-of-care and clinical laboratory markets, today announced the launch of its new test for the detection of Legionella antigen in urine. The product is a rapid lateral flow test for the qualitative detection of Legionella pneumophilia in urine from patients with symptoms of pneumonia. The test can be performed by a health care professional and the result is obtained within 15 minutes.
The Legionella Urinary Antigen (LUA) test utilises Trinity's proprietary Uni-Gold™ platform technology which is the same technology as Trinity's Uni-Gold™ HIV product. Trinity's Uni-Gold™ LUA test is CE Marked and is now available in Europe, Asia Pacific and Latin America. Uni-Gold™ LUA will be submitted to the FDA in August and is expected to be available in the US in Q1 2008.
Legionellosis is an infection caused by the bacteria, Legionella pneumophilia which is an ubiquitous aquatic organism that thrives in warm climates and causes 90% of Legionnaire's disease cases. Legionellosis classically presents as two distinct clinical entities, Legionnaire's disease, a severe multi-system disease involving pneumonia in which the fatality rate has ranged from 5 to 30% in previous outbreaks, and Pontiac fever a milder self-limiting flu-like illness without pneumonia.
Approximately 80% of Legionella patients excrete soluble Legionella antigen in their urine. This presents the opportunity for rapid detection of LUA in urine specimens which allows for early initiation of antimicrobial therapy thus significantly reducing the mortality associated with the disease.
Up to 18,000 people per year contract Legionnaire's disease in the United States, while in Europe the number is over 10,000 per year. It is estimated that over 500,000 rapid tests for LUA are performed per year with an approximate market value of $10 million.
Commenting on the launch of Uni-Gold™ LUA, Brendan Farrell, President of Trinity Biotech said, "The settlement last year of our litigation with Inverness Medical Innovations, Inc (AMEX:IMA ) strengthened our intellectual property position with respect to lateral flow technology. As a result, Trinity implemented a strategy of significant investment in the Research & Development of rapid tests with a goal to develop a broad portfolio of products on our Uni-Gold™ platform. This strategy allows us to leverage our virtually unrivalled intellectual property position with respect to lateral flow. The launch of our Uni-Gold™ LUA is the first product to be developed and marketed as a result of this strategy."
Trinity Biotech develops, acquires, manufactures and markets diagnostic systems, including both reagents and instrumentation, for the point-of-care and clinical laboratory segments of the diagnostic market. The products are used to detect infectious diseases and blood coagulation disorders, and to quantify the level of Haemoglobin A1c and other chemistry parameters in serum, plasma and whole blood. Trinity Biotech sells direct in the United States, Germany, France and the U.K. and through a network of international distributors and strategic partners in over 75 countries worldwide. For further information please see the Company's website: www.trinitybiotech.com.
Forward-looking statements in this release are made pursuant to the "safe harbor" provision 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.
Source: Trinity Biotech
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