Molecular diagnostics company Genedrive (LON: GDR) announced the publication of a large independent multi-centre study evaluating the real-world performance of the Genedrive HCV -ID Kit in low and middle-income countries.
The AIM-listed company said the study yielded 96.2 – 100% sensitivity specifications and specificity specifications of 98.7 – 99.5%, depending on the site or viral load.
Shares of Genedrive rose to 73p after the open in London on Friday.
“The authors highlight a test fail rate of only 1.6%, showing that the Genedrive® system performs to this high standard even though the system operators in the study had no previous experience in molecular testing,” stated Genedrive.
The study took place in Georgia and Cameroon and was published in the journal Diagnostics. It enrolled 426 participants with different demographic backgrounds, with the Georgian participants almost all intravenous drug users, a key patient population for HCV infection.
The Genedrive sensitivity and specificity results were obtained by comparison to testing with the Abbott RealTime HCV Assay. The study was conducted by The Foundation for Innovative New Diagnostics (FIND), with grant funding provided by Unitaid.
The company said that the findings also corroborate other key performance capabilities of Genedrive’s HCV kit, including the ability of the kit to identify all major HCV genotypes, the utility of requiring small volumes of plasma, and the lack of hazardous chemicals in the construction of the kit, allowing for normal disposal processes.
David Budd, Chief Executive Officer of genedrive plc, said: “While the performance results are as expected and excellent, it is equally gratifying to see these achieved with operators with no previous experience in molecular testing.
“Moving testing from highly complex and automated central hospital settings towards more simple decentralised settings is a balance of technological complexity, cost, performance, and usability, which is not always an easy balance to achieve.
“This study is an excellent demonstration of real world performance and the ability of Genedrive to contribute to fighting HCV in resource limited settings.”
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