To: James Strauss who wrote (6335 ) 7/5/2000 12:33:05 PM From: James Strauss Read Replies (1) | Respond to of 13094 TRIBY... TRIBY was mentioned here about a month ago... Here is a news release on an FDA approval... Jim Friday June 30, 7:30 am Eastern Time Company Press Release SOURCE: Trinity Biotech plc Trinity Biotech Receives FDA Clearance for the ENA Profile ELISA DUBLIN, Ireland, June 30 /PRNewswire/ -- Trinity Biotech plc (Nasdaq: TRIBY - news) today announced that it has received Food and Drug Administration (FDA) marketing clearance for the CAPTIA(TM) ENA Profile ELISA. The CAPTIA(TM) ENA Profile ELISA is used as an aid in the diagnosis of autoimmune disease such as Systemic Lupus Erythematosus, (SLE), scleroderma, Dermatomyositis and Sjogrens Syndrome (SS). Over 5 percent of adults in the US & Europe suffer from autoimmune disease, and these conditions are most frequent in individuals over 70 years of age. This segment is increasing rapidly due to the aging of the world's population. Diagnosis of serum auto-antibodies frequently provides valuable information for both diagnosis and treatment. Autoimmune testing is specified by primary care sources, and as a result, the volume of testing is quite high. Growth rates for autoimmunity testing are constantly increasing with an annual market potential for autoimmunity tests at around 50 million in the US and 70 million tests from the rest of the world. Total market revenue potential is expected to reach $200 million and $350 million, respectively. The current FDA approval allows Trinity to sell a product that gives diagnostic information for six different autoimmune diseases from one blood sample. (SLE, MCTD, Sjogrens Syndrome, Scelroderma, Polymyositis, and Dermatomyositis.) This type of testing allows clinical laboratories to be more efficient in their autoimmune testing algorithms. Ronan O'Caoimh, Trinity Biotech's Chairman and CEO commented, ``Trinity is pleased to announce that with the FDA clearance of this product, we now have all 22 of our CAPTIA(TM) autoimmune ELISAsFDA cleared. Autoimmunity is one of the last areas of diagnostic laboratory tests to convert to ELISA technology, and we now offer a broad range of FDA cleared CAPTIA(TM) products. Due to the recent acquisition of MarDx Diagnostics, western blots and immunofluorescence assays have been added to our autoimmune product range, making the range one of the most comprehensive in the world. We are successfully selling this range in 38 countries around the world and intend to increase our market penetration and maximize our growth in the 65+ age category.'' 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 80 countries through 280 international distributors and strategic partners. 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 commercialisation and technological difficulties, and other risks detailed in the Company's periodic reports filed with the Securities and Exchange Commission. For further information, contact: investors, Mark Alvino, 212-698-1360, mark@allencaron.com, or media, Seth Feller, 949-474-4300, seth@allencaron.com, both of Allen & Caron Inc, for Trinity Biotech plc; or Brendan K. Farrell, President of Trinity Biotech plc, 01/2769800, bkf8@aol.com. SOURCE: Trinity Biotech plc biz.yahoo.com