David Budd, Chief Executive Officer of genedrive plc, said: “Since signing our distribution
agreements with Sysmex, we have continued to build momentum in the market and we are
pleased to see initial commercial sales. An ongoing process of registering the products in target
countries will naturally lead to a growing opportunity, and we are confident that as the first to
market decentralised qualitative molecular HCV test, Genedrive® is uniquely positioned to meet
this need.”
With the advent of new ‘curative’ direct acting antiviral treatments for Hepatitis C (HCV),
genedrive and Sysmex 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. These first sales mark a further important step
towards that goal.
The Genedrive® HCV ID Kit, a qualitative molecular assay for HCV has received CE-IVD
Certification from the EU. Recently announced field study results demonstrated the robust
performance of the HCV test in a third party setting and on samples from sub-Saharan Africa
with demonstrated sensitivity and specificity of 100% compared to the Abbott M2000 HCV Real
time assay as a reference. The test also demonstrated efficiency of 95.4% (result achieved at
first attempt).
genedrive plc has signed a distribution agreement with Sysmex Europe GmbH, a subsidiary of
Sysmex Corporation, for the Genedrive® HCV ID Kit and Genedrive® platform in the EMEA
region with an initial focus on Africa. genedrive plc has also entered into a distribution
agreement with Sysmex Asia Pacific Pte Ltd, a subsidiary of Sysmex Corporation, for its CEmarked
Genedrive® HCV ID Kit and Genedrive® platform in the Asia Pacific region.
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