Genedrive Regulatory News (GDR)

RNS

For release: 17 November 2016

genedrive plc ("genedrive" or the "Company")

genedrive plc Announces CE-IVD Certification for Genedrive® Human Genotyping Test

Approval of IL28B Test Further Validates Genedrive® Platform for Rapid Point of Care Human Genotyping

genedrive plc (LSE: GDR), the near patient molecular diagnostics company, today announces the CE-IVD certification of its rapid Genedrive® IL28B SNP human genotyping test. The test is performed in 50 minutes from a buccal cheek swab using the Genedrive® hand-held real-time PCR instrument. The CE-IVD certification further validates Genedrive® as a technology platform for pharmacogenomics.

David Budd, CEO of genedrive plc, said: "We are now looking to partner with Pharma and Contract Research Organisations to support the development of SNP assays for clinical trials and clinical applications. Through our development of the IL28B test, we have defined a rapid pathway for the generation of a quick, accurate, and effective human genotyping tests that can be deployed at the point of need. While the treatment of HCV has evolved since we started the EU sponsored IL28B programme, the outcome clearly shows how our innovative technology can be put into practice in pharmacogenomics applications."

The Genedrive® platform and its polymorphism genotyping capabilities make it an appropriate solution for on the spot stratification, negating the need for costly and time consuming patient recall whilst central laboratory tests are processed. Similarly, the low instrument cost, simplicity of operation, and connectivity options make it an ideal platform for deployment to large numbers of coordinated trial sites.

The data supporting the CE-IVD application showed that the Genedrive® human genotyping IL28B SNP test was 100% accurate in detecting inherited genetic polymorphisms in HCV patients when compared to the current 'gold-standard' laboratory test (Roche TaqMan® PCR). Genedrive® produces results in 50 minutes 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.

The company announced in August that that the Genedrive® 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 treatments on HCV Genotype 1 patients (http://www.stop-hcv.ox.ac.uk/stop-hcv-1-trial).

- Ends -

For further details please contact:

genedrive plc

David Budd: CEO +44 (0)161 989 0245

Peel Hunt LLP

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 molecular 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.com