Genedrive Regulatory News (GDR)

For release: 16 October 2017

The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulation (EU) No. 596/2014. Upon the publication of this announcement via the Regulatory Information Service, this inside information is now considered to be in the public domain.

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

genedrive signs distribution agreement with Sysmex Europe GmbH("Sysmex Europe")

 Sysmex Europe to target commercial HCV opportunity in Africa

genedrive plc (AIM: GDR), the near patient molecular diagnostics company, today announces that it has signed a distribution agreement with Sysmex Europe GmbH, a subsidiary of Sysmex Corporation, a world leader in clinical laboratory systemization and solutions, for the Genedrive® HCV ID Kit and Genedrive® platform in the EMEA region with an initial focus on Africa. genedrive and Sysmex Europe anticipate commercialisation beginning in the coming months targeting end users in decentralised laboratories in multiple countries in Africa, with the rest of the EMEA region to follow.

With the advent of new 'curative' direct acting antiviral treatments for Hepatitis C (HCV), genedrive and Sysmex Europe 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. genedrive's HCV test is the first to market as a decentralised qualitative molecular HCV test for use at the point of need. This agreement follows the recent CE-IVD Certification from the EU for Genedrive® HCV ID Kit, a qualitative molecular assay for HCV.

genedrive will retain responsibility for product development, quality management, and manufacturing while Sysmex Europe will be responsible for sales, marketing, customer support and distribution activities across the EMEA region. Working together, the companies will now focus on securing the required regulatory approvals in individual territories of Africa and genedrive anticipates commercial traction during the 2017/2018 financial year.

"We are very pleased to have Sysmex as our first commercial partner for our HCV test, and our agreement represents an important step to provide access to Genedrive® across target countries in the African regions," said David Budd, CEO of genedrive plc. He added, "Sysmex is a highly respected global organisation with the experience and networks needed to market and commercialise our products."

Matthias Voelkel, Senior Executive Officer of Sysmex Europe GmbH stated, "With this agreement Sysmex further expands its portfolio of products to meet important diagnostic needs in Africa. In line with our company's mission of 'Shaping the advancement of healthcare', we as a company are committed to address the specific challenges of this region. We expect that providing healthcare professionals with a quick diagnostic result in a decentralised setting will allow them to further improve the management of Hepatitis C infections."

Genedrive® HCV ID Kit is a qualitative HCV assay, providing results within 90 minutes and the assay is designed for use in a decentralised testing environment. It is performed on the company's portable molecular diagnostics platform, Genedrive®.

The person responsible for the release of this announcement on behalf of the Company is Matthew Fowler, Chief Financial Officer.

- Ends -

For further details please contact:

genedrive plc

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

Matthew Fowler: CFO

Sysmex Europe GmbH

Fernando Andreu: Senior Executive Officer +49 40 527 260

Jens Behrens: Director, Marketing Communications

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 test have been launched in India and a Genedrive® HCV test has received CE-IVD Certification.

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.