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Successful Clinical Results - Genedrive HCV Assay
Successful Clinical Results - Genedrive HCV Assay.
About this update from Genedrive Plc
[{"type":"text","content":"\n \nRNS Number : 7467Y Genedrive PLC 08 March 2017 \n\nFor release: 8th March 2017\n \ngenedrive plc (\"genedrive\" or the \"Company\")\n \n \nSuccessful Clinical Results for Genedrive® HCV Assay\n \nExternal Validation Studies Show Sensitivity of greater than 99% and Specificity of 100% for Hepatitis C Assay Designed for Decentralised Use in Resource Limited Settings\n \n \ngenedrive plc, the near patient molecular diagnostics company, today announces that it has successfully completed clinical validation studies to support a submission for CE regulatory approval of its Genedrive® HCV ID Kit.\n \nThe studies, performed at Institut Pasteur, Paris, and Queen's Medical Centre, Nottingham, demonstrated an overall sensitivity of greater than 99% and specificity of 100% over a 955 sample cohort, comparing the test to the Abbott Molecular RealTime HCV Viral Load Assay. The Genedrive® HCV ID Kit sensitivity, specificity, and limit of detection meet the Target Product Profile specifications for decentralised use in resource limited settings, as outlined by the Foundation for Innovation in Diagnostics (FIND). The validation studies were supported by the European Commission FP7 PoC-HCV programme.\n \nThe HCV test is performed on the Company's Genedrive® portable molecular diagnostics platform, designed for use at the point of need. The assay uses only a small amount of human plasma (25ul), eliminating the need for a separate RNA viral extraction process, and yields results within 90 minutes. \n \n\"Recently approved direct acting antiviral therapies have revolutionised therapeutic options for treating HCV patients, however the challenge remains to identify infected persons, many of whom are living in geographic regions that lack access to state-of-the-art diagnostics,\" said Dr Darragh Duffy of the Institut Pasteur. \"The Genedrive® HCV ID Kit is a rapid and simple to use point of need test that would enable real-time treatment and management of chronic HCV patients in decentralised settings.\"\n \n\"We are very pleased with the performance of the assay's sensitivity, specificity and speed. This presents the Genedrive® HCV test with the opportunity to be the first to market as a decentralised, qualitative, molecular HCV test,\" said David Budd, Chief Executive Officer of genedrive p...