Genedrive PLC’s (LON:GDR) new hepatitis C diagnosis kit scored almost perfect marks in validation studies in Nottingham and Geneva that will be used as the basis for a European regulatory application.
The studies, performed at Queen's Medical Centre and Institut Pasteur, demonstrated an overall sensitivity (accurate diagnosis) of greater than 99% and specificity (people don’t have disease) of 100% over a 955 sample cohort compared to the Abbott Molecular RealTime HCV Viral Load Assay.
Genedrive is preparing a submission for a European CE mark for its hand-held device and the HCV test is performed using its portable molecular diagnostics platform, which is designed for use at the point of need.
The test is aimed decentralised use in areas with limited or non-existenthealth care infrastructure. The assay uses only a small amount of human plasma (25ul), eliminating the need for a separate RNA viral extraction process, and yields results within 90 minutes.
“The challenge remains to identify infected persons, many of whom are living in geographic regions that lack access to state-of-the-art diagnostics," said Dr Darragh Duffy of the Institut Pasteur.
“Genedrive’s HCV ID Kit is a rapid and simple to use point of need test that would enable real-time treatment and management of chronic HCV patients in decentralised settings,” he added.
David Budd, Genedrive’s chief executive, said he was very please with verification of the assay's sensitivity, specificity and speed.
“This presents the Genedrive HCV test with the opportunity to be the first to market as a decentralised, qualitative, molecular HCV test."
Current world health guidelines recommend treatment after a HCV molecular test.