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.
