NEW YORK (GenomeWeb) – Genedrive said today that has signed a distribution agreement with Sysmex Europe for the Genedrive HCV ID kit and Genedrive platform.
The companies plan for initial commercialization in the coming months targeting end users in decentralized laboratories in multiple countries in Africa, with the rest of Europe, the Middle East, and Africa (EMEA) to follow.
Genedrive will maintain 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. The companies will focus on on securing required regulatory approvals in the individual territories of Africa.
"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," Genedrive CEO David Budd said in a statement.
The companies believe that there is a major opportunity to support the global challenge of addressing hepatitis C (HCV) if accurate, decentralized diagnostics can be used to identify patients living with HCV and provide access to therapy. The Genedrive HCV assay runs on the Genedrive PCR platform, and provides results directly from plasma samples without a separate viral RNA extraction step.
"We expect that providing healthcare professionals [in Africa] with a quick diagnostic result in a decentralized setting will allow them to further improve the management of hepatitis C infections," Sysmex Europe senior executive officer Matthias Voelkel said in a statement.
This agreement follows Genedrive's CE-IVD certification in September for its Genedrive HCV ID kit.