Genedrive Regulatory News (GDR)

For release: 27 March

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 for India with ARKRAY Healthcare pvt Ltd for Genedrive® HCV ID Kit and Genedrive® platform

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 ARKRAY Healthcare pvt Ltd ("ARKRAY"), a wholly owned subsidiary of leading IVD company ARKRAY Inc. Japan, for its CE marked Genedrive® HCV ID Kit and Genedrive® platform in India.

Under the agreement, genedrive will retain responsibility for product development, quality management and manufacturing, and ARKRAY will be responsible for sales, marketing, customer support and distribution activities across the region. Working together, the companies will initially focus on securing the required regulatory approvals in India for the Genedrive® HCV ID Kit. genedrive anticipates commercial activities to subsequently commence during the latter part of its 2018/19 financial year.

David Budd, CEO of genedrive, commented: "We are extremely pleased to extend our commercial reach into India with ARKRAY, who have established an extensive and respected diagnostic sales and support business in the Indian market. This agreement provides access to another important and very relevant region for Genedrive® through a world class commercial partner." 

Mr Tadashi Inoue, President and CEO of ARKRAY Healthcare pvt Ltd, commented: "The Genedrive® HCV ID Kit can provide a rapid diagnostic result in a decentralised setting and has the potential to help tackle the burden of this disease. We look forward to incorporating the Genedrive® HCV ID Kit into our offering for diagnosis and testing in India."

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

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 Genedrive® HCV ID Kit has received CE-IVD Certification and has recently been launched in Africa. genedrive has distribution agreements with subsidiaries of Sysmex Corporation for the distribution of the Genedrive® platform in EMEA and SE Asia (ex India), and with ARKRAY Healthcare pvt Ltd for the distribution of the Genedrive® HCV ID Kit and Genedrive® platform in India.

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

About ARKRAY Healthcare Pvt Ltd

ARKRAY Healthcare, located in Mumbai, India is a 100% subsidiary of ARKRAY Inc Japan. The Company has had a strong presence in India since 2007 through its manufacturing, sales and distribution network. ARKRAY is a leading IVD company and have global footprints in more than 80 countries where it markets a wide range of IVD products in the self-care, POC and Lab Diagnostics segments. In the past few years, ARKRAY has been aggressively expanding its portfolio into niche markets by partnering with global companies and launching their products in the Indian market. The partnership with genedrive plc for the launch of their Genedrive platform is another step in this direction.

Further details can be found at: www.arkray.co.in/english and www.arkray.co.jp/english.

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 71 million people 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 well over 90%, however, access to rapid, inexpensive and accurate diagnostics are a critical bottleneck that must be addressed to eradicate HCV.