Business
Announces Successful Assessment of Genedrive
Announces Successful Assessment of Genedrive.
About this update from Genedrive Plc
[{"type":"text","content":"\n \nRNS Number : 3997P Epistem Holdings plc 18 February 2016 \n\n \n \n \nRNS Press Release\nFor release: 18 February 2016\n \nEpistem Announces Successful External Assessment of Genedrive® Hepatitis C Test at\nthe Institut Pasteur and Commencement of Clinical Studies \n \nEpistem Holdings Plc (LSE: EHP), the personalised medicine and biotechnology company, announces today that its Genedrive® point of care Hepatitis C (\"HCV\") test has successfully completed its first external assessment. The assessment was conducted on reference material and patient samples at the Institut Pasteur, Paris, and its success allows clinical trials of the HCV test to commence, in anticipation of regulatory approval and market launch in the EU during 2017.\n \nThe qualitative HCV test, which is proprietary to Epistem, has been developed for use on its Genedrive® platform in collaboration with Inserm, the French National Institute of Health and Medical Research, under a €6m funded programme supported by the European Commission's 7th Framework HCV programme (EU FP7 PoC-HCV, www.poc-hcv.eu) which commenced in September 2013. \n \nThe Genedrive® qualitative HCV test detects viral RNA, covers all HCV genotypes and is performed at \"point of need\" medical centres directly on plasma without the requirement for complex laboratory equipment or highly trained operators. The test is completed within 90 minutes and has shown excellent alignment to target product profile specifications for HCV, as specified by the Foundation for Innovative New Diagnostics (FIND)1.\n \nAn estimated 150 - 200 million people are understood to be living with chronic HCV viral infection and some 350,000 people die each year from HCV related diseases. The advent of Direct Acting Antiviral Drugs promises to revolutionise the treatment of HCV but to maximise their impact qualitative diagnostic testing will be required. The new Genedrive® HCV test has been developed to address this need, particularly in parts of the world where access to centralised diagnostic laboratories is limited.\n \nDr Darragh Duffy, programme co-coordinator of the EU FP7 PoC-HCV programme, said: \"We are pleased to have successfully demonstrated the performance of the Genedrive® HCV test in this initial assessment at the Institut Pasteur and we look forward to f...