TED.L Regulatory News (TED)

10 Aug 2005 07:01

Tepnel Life Sciences PLC10 August 2005 August 10th 2005 TEPNEL RECEIVES FDA 510(k) CLEARANCE FOR DNA TYPING SYSTEM Tepnel Life Sciences PLC (AIM: TED), the UK-based international ResearchProducts & Services and Molecular Diagnostics group, announces today that itsLifecodes DNA typing kits for HLA-A, HLA-B, HLA-C, HLA-DQB and HLA-DRB havereceived 510(k) marketing clearance from the U.S. Food and Drug Administration(FDA) for use with the Luminex 100 instrument system. Lifecodes is a multi-testsystem designed for use in laboratories serving the solid organ and bone marrowtransplantation field. This approval follows the FDA clearance received in July2004 for Tepnel's antibody products to be marketed for In Vitro Diagnostic (IVD)use. The worldwide market for transplant diagnostics is estimated to be about $150million with the U.S.A. representing approximately $60 million. Additionally, anew application in this field is post-transplant monitoring, which has onlyrecently been adopted by the leading transplant centres and is growing at anestimated rate of nearly 20% per annum. The competitive advantage of these kits with the Luminex 100 instrument systemis that they are highly automated, minimising the chance of sample loss orcontamination. Labour and consumables costs are dramatically reduced compared tomanual tests and the throughput is the highest of any commercial assay. Ben Matzilevich, Tepnel CEO, commented: "We are delighted to report this 510(k)marketing clearance which will enable us to commence marketing these kits forIVD use in the U.S.A. Since 2001 these kits have been marketed for research useonly and we will now be able to access the world's largest market for DNAtyping, following our entry into Europe with CE marked DNA and antibody kits forIVD use in 2004. We envisage that these kits will make a substantialcontribution to Tepnel's Lifecodes business within the next 12 to 18 months. " About Tepnel Tepnel Life Sciences (TLS) is a UK based international biotechnology company.The Company has laboratories, manufacturing and operations in the USA, UK andFrance with 175 employees. TLS provides test kits, reagents and services to twohighly synergistic markets, these being Molecular Diagnostics and BiomedicalResearch. The company's strategy has been to identify high growth nicheopportunities within these multi-billion pound markets. TLS focuses on theseniche opportunities with internally developed products, patents, expertise andknow-how as well as strategic acquisitions, to develop a leadership positionwithin these defined market segments. Enquiries: Ben Matzilevich, Chief Executive Officer, Tepnel Life Sciences plc 0161 946 2200Gron Ffoulkes-Davies, Finance Director, Tepnel Life Sciences plc 0161 946 2200Mark Percy, Seymour Pierce Limited 0207 107 8000Richard Anderson, De Facto Communications Ltd 0207 940 1000 This information is provided by RNS The company news service from the London Stock Exchange