Euroopan markkinoille on tulossa uusi borrelioositesti. Testi perustuu kuitenkin edelleenkin vasta-aineiden toteamiseen (IgM, IgG).
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Trinity Biotech Announces the Launch of New Lyme Products for the European Market
MarketwireJanuary 24, 2008: 08:00 AM EST
Trinity Biotech plc (NASDAQ: 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 Lyme Enzyme Immunoassay (EIA) products specifically designed for the European market.
The new products, the Trinity Biotech EU Lyme IgG + VlsE EIA and the EU Lyme IgM EIA are designed for use as screening assays in clinical laboratories. They are qualitative serological tests for the detection of IgG and IgM antibodies to the most prevalent and clinically important Borrelia species in Europe, i.e. Borrerlia afzelii, Borrelia garinii, and Borrelia burgdorferi. The addition of VlsE to the product significantly boosts sensitivity of the assay. These new products complete Trinity Biotech's product offering for Lyme Disease in Europe, complementing the existing EU Lyme Western Blot confirmatory assays.
Borrelia species cause Lyme Disease in humans following transmission via a tick bite. Lyme Disease is the most common tick-borne disease in the EU. The most frequent symptoms include skin rash, diffuse flu-like reaction and joint pains. The characteristic rash is not always present making diagnosis more difficult. If untreated or inadequately treated, neurological, cardiac, or serious joint abnormalities may follow.
Eurosurveillance (www.eurosurveillance.org) reports that the incidence of Lyme Disease is on the increase across Europe with particularly high increases seen in Northern and Eastern Europe. The continued expansion of this market segment is driven by factors that increase exposure to ticks. Greater participation in outdoor activities such as hiking, hunting and fishing and recent milder winters have contributed to the proliferation of tick numbers with a consequent increased incidence of Lyme Disease.
"Due to the diverse nature of clinical symptoms, diagnosis of Lyme Disease is difficult, thus making confirmation with a diagnostic assay always advisable. The excellent performance of Trinity's new EIAs in combination with the existing EU Lyme Western Blot products will provide invaluable information to clinicians to aid diagnosis," commented Brendan K. Farrell CEO of Trinity Biotech. "Trinity Biotech is the global leader in Lyme Disease diagnostics. The launch of our new EU Lyme EIA assays extends our product offering to European customers. Trinity now offers both screening and confirmatory assays to all markets, thus reinforcing its number one position for Lyme detection in the world."
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.
Trinity Biotech plc