Epistem Holdings Plc: Successful Clinical Trial validates use of Genedrive(R) in Human Genotyping Application

MANCHESTER, UNITED KINGDOM--(Marketwired - May 3, 2016) - Epistem Holdings Plc (LSE:EHP), the molecular diagnostics, personalised medicine and biotechnology company, today announces the successful completion of an independent clinical trial of its Genedrive® point of care IL28B SNP human genotyping test. The clinical trial was conducted by teams from the Institut Pasteur and Hopital Cochin, Paris in the context of the FP7 funded PoC-HCV project (www.poc-hcv.eu).

The clinical trial showed that the Genedrive® human genotyping IL28B SNP test was 100% accurate in detecting inherited genetic polymorphisms in Hepatitis (HCV) patients when compared to the current 'gold-standard' laboratory test (Roche TaqMan® PCR). Genedrive® produces results in 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.

David Budd, CEO of Epistem, commented: "The result from this clinical trial is excellent external validation of our Genedrive® device both as a robust diagnostic system and as a technology platform in the rapidly growing field of pharmacogenomics and follows on from our recently announced launch in India of our tuberculosis and antibiotic resistance test. As medicine becomes more personalised, there is an increasing need to detect genetic differences in patients. We have efficiently demonstrated Genedrive®'s ability to undertake rapid genotyping in a simple manner. This performance study allows us to initiate opportunities for collaboration with pharmaceutical partners in developing companion diagnostic tests for drug development and patient stratification."

Dr Darragh Duffy, programme coordinator of the EU FP7 PoC-HCV programme, said: "Our study recruited 246 HCV patients of different stages and genotypes. The primary endpoint was accuracy of detection in the IL28B gene of CC genotype versus non-CC compared to the TaqMan® Allelic Discrimination Assay. The secondary endpoint was accuracy of detection of CC, CT and TT genotypes again versus TaqMan®. Both endpoints were met with 100% accuracy. We are currently preparing the results of the assay development and validation for publication in a peer-reviewed journal."

Dr Stanislas Pol, M.D Ph.D, Co-Director of the Immunobiology of Dendritic Cells Unit at Institut Pasteur, Paris and lead clinical investigator of the study, said: "This study shows that genetic testing is feasible in a point of care context. While our original goal of using the IL28B polymorphism as a predictor of sustained virologic response in HCV patients treated with interferon regimens may have lost some clinical interest (at least in western countries) with the availability of pangenotypic oral drugs, our study opens the door for development of additional tests, including the rapid qualitative detection of HCV RNA, which is our next priority for the screening of HCV infection and the monitoring of therapeutic intervention."