Genedrive Regulatory News (GDR)

For release: 11 April 2017

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

Hepatitis C Assay performance data accepted for presentation at the International Liver Confrence (EASL) , April 19-23 in Amsterdam

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.

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For further details please contact:

genedrive plc

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

Matthew Fowler: CFO

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 assay has been launched in India.

Further details can be found at: www.genedriveplc.com and www.genedrive.com 

About Hepatitis C

Hepatitis C is an international public health challenge, comparable to other major communicable diseases, including HIV, tuberculosis and malaria. It is estimated that 150-200 million people, or approximately 3% of the world's population, are living with chronic hepatitis C, and more than 350,000 people die yearly from hepatitis C related diseases. In 2016, WHO published the first global health sector strategy on Hepatitis with a goal of eliminating viral hepatitis as a major public health threat by 2030. New oral, well-tolerated treatment regimens can achieve cure rates of over 90% however access to rapid, inexpensive and accurate diagnostics are a critical bottleneck that must be addressed to eradicate Hepatitis C.

Further details on the PoC-HCV project can be found at http://www.poc-hcv.eu/index.php