Genedrive Regulatory News (GDR)

For release: 13 March 2018

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

Commercial sales of Genedrive® HCV ID Kit and platform begin

Decentralised molecular HCV assays shipped to Africa

genedrive plc (AIM: GDR), the near patient molecular diagnostics company, today announces that is has commenced commercial sales and shipments of its Genedrive® HCV ID Kit and Genedrive® platform into the EMEA region. The products have been shipped to genedrive's distributor, Sysmex Corporation ("Sysmex"), a world leader in clinical laboratory systemization and solutions, and are now destined for use in various initial target countries. In addition, first commercial sales and shipments of the Genedrive® HCV ID Kit and Genedrive® platform are expected to commence in the Asia Pacific region in the coming weeks.  

David Budd, Chief Executive Officer of genedrive plc, said: "Since signing our distribution agreements with Sysmex, we have continued to build momentum in the market and we are pleased to see initial commercial sales. An ongoing process of registering the products in target countries will naturally lead to a growing opportunity, and we are confident that as the first to market decentralised qualitative molecular HCV test, Genedrive® is uniquely positioned to meet this need."

With the advent of new 'curative' direct acting antiviral treatments for Hepatitis C (HCV), genedrive and Sysmex believe that there is a major opportunity to support tackling the global burden of the disease if accurate, decentralised diagnostics can be used to identify those living with HCV and give them access to therapy. These first sales mark a further important step towards that goal.

The Genedrive® HCV ID Kit, a qualitative molecular assay for HCV has received CE-IVD Certification from the EU. Recently announced field study results demonstrated the robust performance of the HCV test in a third party setting and on samples from sub-Saharan Africa with demonstrated sensitivity and specificity of 100% compared to the Abbott M2000 HCV Real time assay as a reference. The test also demonstrated efficiency of 95.4% (result achieved at first attempt).

genedrive plc has signed a distribution agreement with Sysmex Europe GmbH, a subsidiary of Sysmex Corporation, for the Genedrive® HCV ID Kit and Genedrive® platform in the EMEA region with an initial focus on Africa. genedrive plc has also entered into a distribution agreement with Sysmex Asia Pacific Pte Ltd, a subsidiary of Sysmex Corporation, for its CE-marked Genedrive® HCV ID Kit and Genedrive® platform in the Asia Pacific region.

- Ends -

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

About genedrive plc

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 and a Genedrive® HCV test has received CE-IVD Certification and has been launched in Africa. genedrive has distribution agreements with subsidiaries of Sysmex Corporation for the distribution of the Genedrive® platform in the EMEA and Asia Pacific regions.

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

About Sysmex Europe

Sysmex Europe GmbH (SEG), located near Hamburg, Germany, is a subsidiary of the Sysmex Corporation from Kobe, Japan. From our Hamburg offices - designated a Great Place to Work® in 2014 and 2016 - we serve our affiliates, distributors and customers throughout EMEA - Europe, the Middle East and Africa. Globally we employ around 8000 staff, of whom 1300 work in the EMEA region.

Sysmex is the global leader in haematology and a renowned specialist in haemostasis, urinalysis, and laboratory automation. As our expertise in the interdependency of disease and medical disciplines grows, we are growing to cover other pressing areas such as oncology, flow cytometry, liquid biopsy and essential healthcare in resource-poor regions. This is allowing us to deliver clinical value that primary healthcare workers such as physicians, surgeons and other specialists can use directly to deliver better diagnostics, treatment and monitoring, and so improve the quality of life of their patients.

Everything we do is driven by a single mission: Shaping the advancement of healthcare.

For more information about Sysmex Europe, please visit www.sysmex-europe.com, and for details on Sysmex Africa www.sysmex.co.za

About Hepatitis C

Hepatitis C (HCV) 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 HCV, and more than 350,000 people die yearly from HCV-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 HCV.