Genedrive PLC (LON:GDR) said analytical performance and field studies of its Hepatitis C (HCV) ID Kit have been published in BMJ Gut, a leading international journal in gastroenterology and hepatology.
The AIM-listed diagnostics company said the publication reports on assay performance data generated and used for its CE-IVD certification, including analytical performance data as well as field performance evaluation.
The paper had concluded that Genedrive’s HCV ID Kit was a rapid, simple, portable and accurate near patient molecular test for HCV, with sensitivity and specificity that fulfils the recent World Health Organization (WHO) target product profile for HCV decentralised testing in low income and middle-income countries.
The group added that pan-genotype performance, with excellent exclusivity for non-HCV pathogens and sensitivity of greater than 98% and speciﬁcity of 100% in samples of European and African origin (including South Africa, Kenya, Ghana, Nigeria, Uganda), was observed and that the test was validated in a real clinical setting in a resource-limited country.
David Budd, Genedrive chief executive, commented: "This high impact peer reviewed publication provides further validation of the performance of our Genedrive HCV ID assay.
He added: “We are first to market with a decentralised qualitative molecular HCV test for use at point of need and believe we have the potential to positively impact the continuum of care from screening to cure by supporting real-time treatment decisions."
Genedrive shares were steady in mid-morning trading Tuesday at 38.5p.
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