Hepatitis C Assay performance data accepted for presentation at the International Liver Conference (EASL), April 19-23 in Amsterdam
genedrive plc will be showcasing its molecular Genedrive® HCV ID Kit and Genedrive® platform at the International Liver Conference taking place in Amsterdam from 19th-23rd April 2017. Clinical validation data for Genedrive® HCV ID Kit will be presented at the meeting by Dr Darragh Duffy from the Institut Pasteur, Paris.
11th Apr 2017
genedrive plc, the molecular diagnostics company, will be showcasing its molecular Genedrive® HCV ID Kit and Genedrive® platform at the International Liver Conference taking place in Amsterdam from 19th-23rd April 2017. Clinical validation data for Genedrive® HCV ID Kit will be presented at the meeting by Dr Darragh Duffy from the Institut Pasteur, Paris. The Genedrive® HCV ID Kit is a qualitative HCV assay, providing results within 90 minutes. The assay is designed for use in a decentralised testing environment and is performed on the company’s portable molecular diagnostics platform. The assay is performed directly from a small volume of plasma (25μl) and does not require a separate viral extraction process . The Genedrive® HCV assay recently demonstrated sensitivity of greater than 99% and specificity of 100% when compared to the Abbott Molecular RealTime HCV Assay. “The Genedrive® HCV assay will allow decentralised laboratories to provide affordable onsite molecular testing for HCV that aligns with recent WHO testing guidelines,” said David Budd, Chief Executive Officer of genedrive plc. “With the wider availability of generic direct acting antiviral agents, the drive in resource limited countries is to cost effectively identify and treat individuals with Hepatitis C. We believe that with the performance achieved by the Genedrive® HCV assay, there is an opportunity to play a very meaningful role in this strategy.”The company has recently submitted the Genedrive® HCV ID Kit for CE certification under the EU Medical Devices Directive. Anyone wishing to receive more information on the assay at launch can register their interest at https://www.genedrive.com/assays/hcv-assay.php.
Genedrive® HCV Assay submitted for CE IVD Certification
Significant Step in Commercialisation of HCV Assay for Decentralised Use in Resource Limited Settings
27th Mar 2017
genedrive plc, the near patient molecular diagnostics company, today announces submission of its Genedrive® HCV ID Kit for CE IVD certification under the EU Medical Devices Directive. Receipt of CE IVD certificaton will allow commercialisation of the product within the EU and in resource limited countries in the rest of the world that accept CE certification under their national regulations. Where local registration is required, CE marking is often a prerequisite.
The application for CE Marking is supported by excellent performance data in recent clinical validation studies. These studies, performed at Institut Pasteur, Paris, and Queen’s Medical Centre, Nottingham, show that the Genedrive® HCV ID Kit sensitivity, specificity, and limit of detection meet the Target Product Profile specifications for decentralised use in resource limited setting as outlined by the Foundation for Innovation in Diagnostics (FIND).
The qualitative molecular HCV assay allows for decentralised testing of Hepatitis C (HCV), providing results within 90 minutes direct from a small plasma sample (25ul). The Genedrive® HCV assay demonstrated a sensitivity of greater than 99% and specificity of 100% over the 955 sample cohort when comparing the assay to the Abbott Molecular RealTime HCV Viral Load test. The assay is performed on the Genedrive® platform, a portable molecular diagnostics system designed for use at the point of need.
Professor William Irving, Professor of Virology at Queens Medical Centre Nottingham, and clinical virology expert in hepatitis diagnosis, management and pathogensis, was the lead investigator at the UK site involved with the clinical performance assessment of the Genedrive® HCV assay.
Professor Irving said, “The diagnostic and treatment landscape for HCV has changed rapidly in recent years, and with the introduction of direct acting antivirals, there is a real opportunity to tackle the global burden of Hepatitis C. Accurate, decentralised diagnostics, like Genedrive® HCV, promise to be a big step forward in addressing the challenges associated with identifying and diagnosing those living with HCV infection and to give them access to this new and effective therapy.”
David Budd, Chief Executive Officer of genedrive plc said, “Application for CE Marking for the Genedrive® HCV assay is a significant step in our development of a decentralised and qualitative molecular HCV test, which could be the first of its kind to market. As we go through this process, we look forward to updating the market with our commercial partnership arrangements and target geographies for initial product introductions.”
Successful Clinical Results for Genedrive® HCV Assay
External Validation Studies Show Sensitivity of Greater Than 99% and Specificity of 100% for Hepatitis C Assay Designed for Decentralised Use in Resource Limited Settings
8th Mar 2017
genedrive 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.
The 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.
The 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.
"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."
"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 plc. "WHO HCV testing guidelines recommend the initiation of treatment with direct acting antiviral agents, following a qualitative or quantitative HCV molecular test. The Genedrive® HCV ID Kit is well placed to support the goal of increasing access to HCV diagnostics in decentralised laboratories in resource limited settings."
The Company anticipates submission for CE certification under the EU Medical Devices Directive for Genedrive® HCV ID Kit by the end of March 2017. CE certification is a key step toward product commercialisation later this year.
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
17th Nov 2016
genedrive plc 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).
Successful clinical trial validates use of Genedrive® in human genotyping application
Epistem Holdings Plc, announced the successful completion of an independent clinical trial of its Genedrive® point of care IL28B SNP human genotyping test.
6th May 2016
External Validation for Rapid Detection of Genetic Polymorphisms
The IL28B SNP human genotyping clinical trial was conducted by teams from the Institut Pasteur and Hopital Cochin, Paris in the context of the FP7 funded PoC-HCV project.
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.
Epistem's diagnostic test performs well in hepatitis trial
Epistem Holdings Plc's (LON:EHP) rapid diagnostic system Genedrive has performed well in EU-funded hepatitis study carried out by Institut Pasteur and Hopital Cochin in Paris.
3rd May 2016
Already launched in India for TB, the clinical trial showed Genedrive was 100% accurate in detecting inherited genetic polymorphisms in Hepatitis (HCV) patients compared to the current 'gold-standard' laboratory test, Roche's TaqMan PCR.
Epistem said Genedrive also produced results in 50 minutes from a simple cheek swab compared to the standard blood sample test that can take 2-3 weeks.
David Budd, Epistem's chief executive, said the trial was excellent external validation of Genedrive both as a diagnostic system and as a technology platform in the rapidly growing field of pharmacogenomics.
"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."
The results should allow it to work with pharma groups to develop companion diagnostic tests, he added.
The study comprised 246 HCV patients of different stages and genotypes.
Dr Stanislas Pol, the lead clinical investigator of the study at the Institut Pasteur, said: "This study shows that genetic testing is feasible in a point of care context.
"The 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."