genedrive plc, a near patient molecular diagnostics company, and the Foundation for Innovation of New Diagnostics (FIND), announced today a study agreement for the performance evaluation of genedrive plc’s hepatitis C virus (HCV) Genedrive® HCV ID Kit. The Genedrive® HCV ID Kit is a qualitative HCV diagnostic assay, performed on the company’s portable molecular diagnostics platform, Genedrive®. The assay is designed for use in low-resource settings, and delivers results in 90 minutes.
Under today’s agreement, FIND will lead evaluation studies in Cameroon and Georgia between September 2018 and May 2019. These studies are designed to confirm the diagnostic accuracy of Genedrive® HCV ID across diverse genotypes, as well as to assess usability in the intended market setting. genedrive plc will provide product in-kind to support the study.
“We are appreciative of the support of FIND in leading these studies,” said David Budd, CEO of genedrive plc. “Positive outcomes should further facilitate our commercialisation activities in these regions, as well as providing important clinical field data that others look to as they decide to implement Genedrive® in their own specific settings.”
FIND’s evaluations of Genedrive® HCV ID Kit will feed into the organization’s broader HCV efforts. FIND is the lead partner on a multi-year, multi-country HCV project funded by Unitaid to support the development of simple HCV diagnostic tools for use at the point of care, which can be made widely available to those who need them.
“These studies are a perfect fit with our ongoing efforts to improve the options for affordable, easy-to-use HCV diagnostics,” said Francesco Marinucci, Head of HCV and HIV at FIND. “We look forward to the results and to ongoing collaboration with genedrive plc.”
The World Health Organization estimated that 71 million people had chronic HCV infections in 2015. If left untreated, HCV can cause serious, lifelong illness or death due to liver cirrhosis. Levels of HCV co-infection with HIV and tuberculosis (TB) are high, meaning failure to address HCV will affect efforts to control both TB and HIV. The global health sector aims to eliminate viral hepatitis as a public health threat by 2030. Given advances in HCV drug development, treatment options have become easier and more affordable. However, similar progress has not been made in HCV diagnostic development. There is a critical lack of easy-to-use, affordable tools for diagnosis at the point of care – an estimated 80% of people living with HCV are not diagnosed.