Genedrive hails ‘excellent’ results from Hepatitis C study for Indian market
has hailed “excellent clinical results” from a study in India of the group’s Hepatitis C virus testing kit which was revealed to be 100% accurate and sensitive.
The objective of the study was to determine the diagnostic accuracy of Genedrive’s HCV ID Ki as a confirmatory test for patients with seropositive hepatitis C virus (HCV), a virus that primarily affects the liver and can cause serious damage, across Indian demographic settings.
The diagnostic accuracy of the kit was evaluated by comparing the test with the Abbott Real time HCV test on the lab-based Abbott m2000 platform in an Indian demographic and across different genotypes to ensure suitability for introduction of the product to the Indian population.
Across India, Genedrive reported that the circulation of the HCV genotype is predominantly genotypes 3 and 1 with live infections of HCV estimated at between six and twelve million.
Shares in Genedrive have skyrocketed by over 550% since April 2020 to open 7.27% higher this morning at 59p following the announcement.
GDR price chart150 HCV RNA positive and 170 HCV RNA negative samples were tested using both methods. The comparison revealed 100% sensitivity (95% CI 97.9 - 100%) and 100% specificity (95% CI 97.9 - 100%) meaning the overall diagnostic accuracy was 100% (95% CI 98.9 - 100%).
Overall, the study demonstrates that the HCV ID Kit is suitable for use in India and can be used for decentralised testing of HCV, thereby reducing the loss of patients to follow up.
“These excellent clinical results for our HCV assay further validate the applicability of the test for a decentralised setting. India is a key target market for our assay and we are excited about the commercial prospects in the region,” said David Budd, Chief Executive of Genedrive.
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