Genedrive said Wednesday that the new generation Genedrive System platform has now received CE-IVD marking ahead of its launch into the UK and EU.
The platform, which was developed to support the commercial launch of the Genedrive MT-RNR1 ID Kit, is used to screen for a genetic mutation called m.1555A>G.
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“If a baby carrying the mutation is given the antibiotic gentamicin, a common treatment for bacterial infections, it can cause lifelong deafness. The Genedrive test allows for the administration of alternative treatments if the mutation is detected, avoiding the life changing impacts and costs of antibiotic induced hearing loss (AIHL),” stated Genedrive.
The company is now beginning its rollout of the Genedrive MT-RNR1 IC Kit in partnership with Inspiration Healthcare as its UK and Ireland distributor, with the first sales expected in autumn 2021.
“Developed in partnership with NHS collaborators, the Genedrive MT-RNR1 Kit and Genedrive System represent several world firsts – the first commercial availability of an MT-RNR1 test, the first use of our new Genedrive platform, and the first use of point of care molecular diagnostics in a neonatal urgent care setting,” said Genedrive CEO David Budd.
The AIM-quoted company believes the total addressable market in the UK and EU is around £35m and has recently raised funds to support commercial activities to encourage sales.
“The excellent clinical and performance data that supports these new innovations puts us in a strong position for commercial roll out in the UK alongside Inspiration Healthcare, our commercial distributors in the UK and Ireland,” added Budd.
“With the EU scheduled to follow early next year, our first EU pilot site is already established, and will serve as a reference site as we target selected EU countries.”
Genedrive shares are currently up 1.2% at 5.3p on Wednesday. However, its shares have declined by over 63% in the last six months.
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