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Genedrive gets CE mark for baby deafness diagnostic test

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."

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The test will be trialed over the next 6-8 months

Genedrive PLC’s (LON:GDR) test for recognising the risk of antibiotic-induced hearing loss in infants has obtained a European standard CE marking.

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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Quick facts: Genedrive PLC

Price: 21.5 GBX

AIM:GDR
Market: AIM
Market Cap: £7.31 m
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Investor Update: Genedrive reports 'high clinical accuracy' for its AIHL...

Headlines from Proactive UK newsroom. Genedrive (LON:GDR) has scored 100% diagnostic sensitivity and 100% specificity in a test of its assay kit to identify babies at risk of hearing loss from the use of antibiotic gentamicin. The clinical study was based on 303 samples. Gold miner...

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