Announcement
Genedrive PLC : Genedrive Assay used in STOP-HCV-1 Clinical Trial
RNS Number : 7346G
Genedrive PLC
10 August 2016
RNS Reach
For release: 10 August 2016
Genedrive® IL28B Genotyping Assay to be used in STOP-HCV-1 Clinical Trial
Genedrive plc (LSE: EHP), the near patient molecular diagnostics company which recently changed its name from Epistem Holdings plc, today announces that its Genedrive® point of care IL28B human genotyping test will be used in the STOP-HCV-1 clinical trial being run by STOP-HCV, a consortium designed to use stratified medicine to optimise the treatment of patients with Hepatitis C Virus infection. The trial is designed to assess the effectiveness of different treatment durations with Direct Acting Antiviral (DAA) treatments on Hepatitis C (HCV) genotype 1 patients (http://www.stop-hcv.ox.ac.uk/stop-hcv-1-trial).
Direct Acting Antiviral (DAA) treatments are a new range of drugs which are replacing interferon and other established treatments for HCV. The new DAA treatments regimens are of a shorter duration (12 weeks or less), are well tolerated and offer a much improved chance of cure than earlier treatments. However, costs remain high and, at present, there are no molecular diagnostic tests to predict patients' response to treatment.
The STOP-HCV-1 clinical trial will assess two NICE approved DAA treatment combinations and whether the addition of another, older drug (ribavirin) has value in short course treatment. The project is funded by the Efficacy and Mechanism Evaluation (EME) Programme, an MRC and NIHR partnership. Around 400 patients are expected to be recruited during 2016 and 2017. The aim is to discover which patients may be cured by shorter courses of therapy and how new techniques in molecular diagnostics, including the Genedrive® IL28B point of care test, may be used to predict patient response. Genedrive will provide 20 Genedrive® units and 400 tests for use in the trial.
The Genedrive® test produces results within 50 minutes from a simple cheek (buccal) swab compared to the standard approach which uses a blood sample and which can have a service lab return time of 2-3 weeks for results. A recent clinical trial showed the Genedrive® IL28B test was 100% accurate at detecting genetic polymorphisms in HCV patients when compared with the current 'gold-standard' laboratory test.
Dr Graham Cooke, Chief Investigator of the STOP-HCV-1 clinical trial, said: "We are pleased to incorporate the Genedrive® IL28B point of care genotyping test in the STOP-HCV-1 clinical trial which aims to identify key markers to guide the duration of treatment required for HCV patients."
David Budd, CEO of Genedrive, commented: "The inclusion of our Genedrive® IL28B genotyping test in the STOP-HCV-1 clinical provides further validation of the potential of Genedrive® in point of care genotype diagnostic testing.
If the STOP-HCV-1 clinical trial demonstrates that the IL28B genotype is a reliable indication of patient response to shortened DAA treatment, we would anticipate a role for the Genedrive® IL28B test in future HCV treatments. The Genedrive® IL28B test has been developed alongside the Genedrive® HCV test which is scheduled for market launch in 2017."
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For further details please contact:
Genedrive plc
David Budd: CEO +44 (0)161 989 0245
John Rylands: Finance Director
Peel Hunt LLP (NOMAD)
James Steel +44 (0)207 418 8900
Oliver Jackson
Consilium Strategic Communications
Chris Gardner +44 (0)203 709 5700
Matthew Neal
Laura Thornton
Notes to Editors
Genedrive plc is a molecular diagnostics company developing and commercialising a low cost, rapid, versatile, simple to use and robust point-of-need or point-of-care diagnostics platform for the diagnosis of infectious diseases and for use in patient stratification (genotyping), pathogen detection and other indications. The Genedrive® platform and MTB/RIF test have been launched in India and a Genedrive® HCV test has been successfully assessed by the Institut Pasteur, Paris.
Genedrive plc was formerly Epistem plc and continues to provide contract research services to drug development companies under the Epistem brand name.
Further details can be found at: www.genedriveplc.com and www.genedrive.co.uk
This information is provided by RNS
The company news service from the London Stock Exchange
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