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."
- Ends -
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
genedrive@consilium-comms.com
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
END
NRAAKCDQDBKBKFK