The handheld device which detects the virus was put through its paces by scientists at a testing laboratory in Johannesburg, South Africa.
AIM-listed Genedrive wanted to show that its HCV ID Kit would work just as well across the diverse genotypes which are prevalent in Africa compared to Europe.
In a cohort of 130 clinical samples from several sub-Saharan countries including South Africa, Kenya and Ghana, the device demonstrated sensitivity and specificity of 100%.
In layman’s terms, that means the HCV ID Kit correctly identified samples with the disease as well as correctly identifying those without.
On top of that, the scientists also found the device easy to operate which, compared to the Abbott M2000 platform, required no maintenance and had faster processing times.
"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 chief executive David Budd.
“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.”
Towards the end of 2017, Genedrive signed a distribution agreement with Sysmex which will see the latter market and sell the HCV ID Kit and Genedrive platform in the EMEA region, with an initial focus on Africa.