28th Feb 2007 07:00
Tepnel Life Sciences PLC28 February 2007 Tepnel Life Sciences plc ('Tepnel' or 'the Company') National Genetics Reference Laboratory (Wessex) Completes Successful Evaluation of Tepnel's Innovative QST*RTM Genetic Testing Kits Manchester, UK, 28th February 2007 Tepnel Life Sciences PLC (AIM: TED), theinternational Molecular Diagnostics and Research Products & Services group,announces the successful evaluation of its ELUCIGENE QST*R genetic testing kitsby the National Genetics Reference Laboratory (NGRL) Wessex. The NGRL (Wessex)carries out independent studies to evaluate new diagnostic services for the NHS.The study concludes that the ELUCIGENE QST*R is a high quality, highlyreliable product, that is easy and simple to use. The ELUCIGENE QST*R is a DNA-based assay for the rapid detection duringpregnancy of common chromosome abnormalities, including Down syndrome, Edwardssyndrome and Patau syndrome. The diagnostic test was developed in collaborationwith Guy's and St Thomas' NHS Trust Hospital in London. It is a highlysensitive and rapid test that can provide results within 4 hours, compared with12-14 days needed for current standard tests. ELUCIGENE QST*R was launchedthroughout Europe in March 2006 and is now used in 30 laboratories in over 15countries. The test has been approved for in vitro diagnostic use in Europe andCanada, and further regulatory approvals are in progress. The global marketsize for prenatal genetic testing is estimated to be in the order of $50m. The NGRL (Wessex) study involved 500 samples tested in three UK diagnosticlaboratories. The report concludes that the ELUCIGENE QST*R is simple and easyto use, was accurate and no false negative/positive results were obtained. TheNGRL (Wessex) report is distributed to diagnostic laboratories through Europeand is available online at http://www.ngrl.org.uk/Wessex/downloads.htm. Ben Matzilevich, CEO of Tepnel, said, "This report provides independentvalidation of the ELUCIGENETM QST*R state-of-the-art diagnostic test. Itprovides a rapid and cost effective alternative to the time consuming standardkaryotyping analysis. Tepnel expects sales of ELUCIGENE QST*R to continue toshow substantial growth in 2007." -End- For Further Information: Tepnel Life Sciences plcBen Matzilevich, CEOCarol SmithTel: 0161 946 2200 Capital MS&LMary Clark or Halina KukulaTel: +44 20 7307 5330Email: [email protected] Notes to Editors About Tepnel Life Sciences plc Tepnel Life Sciences (AIM:TED) is a UK-based international life sciencesproducts and services group with two divisions, Molecular Diagnostics andResearch Products & Services. The Company has laboratories, manufacturing andoperations in the USA, UK and France with 195 employees. TLS provides testkits, reagents and services to two highly synergistic markets, these beingMolecular Diagnostics and Biomedical Research. The company's strategy has beento identify high growth niche opportunities within these multi-billion poundmarkets. TLS focuses on these niche opportunities with internally developedproducts, patents, expertise and know-how as well as strategic acquisitions, todevelop a leadership position within these defined market segments. ELUCIGENE QST*R ELUCIGENE QST*R, a DNA-based diagnostic assay for the rapid prenatal detectionof the common chromosome abnormalities causing Down syndrome, Edwards syndromeand Patau syndrome. Screening for Down syndrome is routinely offered to thousands of women each yearas part of standard antenatal healthcare. For those women identified as beingat high risk of carrying a Down syndrome foetus, amniocentesis or chorionicvillus (CVS) sampling is offered. ELUCIGENE QST*R uses the QF-PCR (Quantitative Fluorescence Polymerase ChainReaction) technique which can provide a definitive diagnosis within 4 hourscompared to standard cytogenetic techniques that can take up to 14 days. Thehighly multiplexed assay, developed in collaboration with Guy's and St Thomas'Hospital in London, is a simple one tube PCR reaction that is analysed on astandard capillary Genetic Analyzer. Tepnel Diagnostics make this powerful technique widely available through aseries of rapid and cost effective kits suitable for analysis of both chorionicvillus and amniotic fluid samples. Approximately 8% of these samples do exhibitan abnormality, the majority of which are the chromosome aneuploidies, trisomy13 (Patau syndrome), trisomy 18 (Edwards syndrome) and trisomy 21 (DownSyndrome). ELUCIGENE QST*R kits are validated and CE marked for IVD use in compliance withEU directive 98/79/EC and are manufactured to ISO 9001:2000/ISO 13485:2003. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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