Genedrive Regulatory News (GDR)

14 November 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 Asia Pacific Pte Ltd for HCV

Agreement extends global commercial coverage

genedrive plc (AIM: GDR), the near patient molecular diagnostics company, today announces that it has signed 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. This is the second agreement signed with a subsidiary of Sysmex Corporation, a world leader in clinical laboratory systemization and solutions, and follows the announcement on 16th October 2017 of a distribution agreement for the EMEA region with Sysmex Europe GmbH.

The agreement with Sysmex Asia Pacific follows the same structure as the agreement with Sysmex Europe, with genedrive retaining responsibility for product development, quality management and manufacturing, and Sysmex Asia Pacific being responsible for sales, marketing, customer support and distribution activities across the region. Working together, the companies will focus on securing the required regulatory approvals in individual territories across Asia. genedrive anticipates some initial traction during the 2017/2018 financial year, with a further ramp up in 2018/19 when regulatory milestones are met. genedrive has retained the rights over the Indian market.

David Budd, CEO of genedrive, commented: "We are extremely pleased to extend our commercial reach with Sysmex Asia Pacific as our commercial partner for our Genedrive® HCV assay. This agreement provides access to another important and very relevant global region for Genedrive® encompassing countries with a high HCV burden." 

Frank Buescher, President and CEO of Sysmex Asia Pacific, commented: "We are excited about this collaboration opportunity with genedrive and incorporating their HCV assay in our unique offering for Liver Disease management in the APAC region."

Genedrive® HCV ID Kit is a qualitative HCV RNA assay, designed for use in a decentralised testing environment to deliver actionable results within 90 minutes. 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 Asia Pacific Pte Ltd

Frank Buescher: President and Chief Executive Officer

Carlum Shiu: Director, Regional Marketing and Scientific Affairs

Carol Low: Manager, Regional Corporate Marketing +65 6221 3626

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 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 Asia Pacific Pte Ltd

Sysmex Asia Pacific Pte Ltd, located in Singapore, is a subsidiary of the Sysmex Corporation from Kobe, Japan. From our Singapore office - we serve our affiliates, distributors and customers throughout South and Southeast Asia, and Oceania. Globally Sysmex Group employs more than 8000 staff, of whom 560 work in the Asia Pacific region.

Sysmex is the global leader in haematology and a renowned specialist in haemostasis and urinalysis. In Asia Pacific, our healthcare solutions include immunoassay and clinical chemistry. As our expertise in the interdependency of disease and medical disciplines grows, we are growing to introduce solutions in other pressing areas such as oncology, flow cytometry, liquid biopsy and essential healthcare, to resource-poor Asia Pacific regions. This is allowing us to deliver the clinical value that primary healthcare workers such as physicians, surgeons and other specialists demand to realise better diagnostics, treatment and monitoring, thereby improving the quality of care of their patients.

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

For more information about Sysmex Asia Pacific Pte Ltd, please visit www.sysmex-ap.com,

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.