The company said its kit represents a ‘step-change’ in rapid testing and provides a positive test result within 7.5 minutes and a negative test result with 17 minutes.
In relation to the latest variant of concern Omicron, the company said while less than 100 genetic sequences had been made public, none of them had mutations affecting the design of its assay.
In a clinical trial of 149 samples the test had a performed very well with sensitivity and specificity readings of 98.2% and 98.9% respectively. This means the test correctly identifies 98.2% of people who have the virus and 98.9% of people without the disease.
The company said the test was ‘several orders of magnitude’ more sensitive than current lateral flow antigen tests. The process to approve the test is expected to take 10 working days to complete, following which the product can go on sale across the EU.
Chief executive David Budd commented: ‘The new Genedrive kit combines the speed and ease of lateral flow testing with molecular level accuracy in a low cost and portable device.
‘We are now able to progress the commercial evaluations of the product to selected partners and given its performance in our studies, we believe there remain substantial market opportunities that can be targeted.
‘As recent news of the Omicron variant demonstrates, Covid-19 remains a significant issue in global health and thus rapid and accurate testing will remain a critical tool in managing the spread of the virus.’
The share have been very volatile over the last two years and hit a peak of 220p in May 2020 during the early weeks of the pandemic.