“These positive results with the genedrive HCV assay in customer hands on local samples confirms that our good clinical validation performance can be translated into real-world settings where the test will be used, ” said David Budd, Chief Executive Officer of genedrive plc. “Our test is the first to market as a decentralised qualitative molecular HCV test for use at the point of need. We remain confident it can play an important role in the diagnosis and management of the disease in Africa and in other territories where access to centralized laboratories is limited.”
Dr Allison Glass, Pathologist-in-Charge at Lancet Laboratories Johannesburg commented, “Our trained laboratory staff found the Genedrive® HCV system and kit easy to operate, and, compared to the Abbott M2000 platform, required no maintenance, had a small laboratory foot print and faster processing time. Many of the original samples were haemolysed but produced valid results first time demonstrating the robustness of using PCR direct from plasma. The genedrive HCV kit has the potential to decentralise clinical management of chronic HCV, which may result in the expansion of treatment programmes to rural areas of resource-limited countries.”
The study follows the recent announcement that genedrive plc 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 plc also entered into 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.
– Ends –
Related articles
