The kit will be used in critical care settings to screen babies for a genetic mutation, MT-RNR1, which if present, can cause lifelong deafness if they are prescribed with the antibiotic gentamicin.
Genedrive believes this is the first genetic-based screening test to be produced commercially to help identify babies with a mutation of the MT-RNR1 gene.
Tests currently are carried out by a hospital’s central genetics department and can take between 3-5 days, whereas Genedrive’s RNR-1 test gives a result in under thirty minutes.
David Budd, Genedrive’s chief executive, said: "CE marking of our RNR1 test allows for the next phase, with implementation evaluation by our NHS partners in Manchester and Liverpool.
“At the same time, we will look to the opportunities outside of the UK where CE marking gives us market entry."
The plan now is to deploy the test in Manchester and Liverpool for the next 6-8 months, to show how it can be successfully implemented in an NHS environment, said Professor William Newman, clinical head of division in genomic medicine at Manchester University NHS Foundation Trust.
Genedrive shares were up 12% to 20.75p on Monday morning.
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