Genedrive shares surge as pre-submission for MT-RNR1 filed to FDA

(Alliance News) - Genedrive PLC on Wednesday said it has started engagement with the US Food & ...

Alliance News 5 October, 2022 | 10:40AM
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(Alliance News) - Genedrive PLC on Wednesday said it has started engagement with the US Food & Drug Administration to progress the approval of its MT-RNR1 product range into the US.

Shares were up 32% to 14.50 pence each on Wednesday morning in London.

Genedrive is a Manchester-based molecular diagnostics company.

The firm said its MT-RNR1 assay is the world's first rapid point-of-care test to "screen infants in an urgent care setting for a genetic variant that will cause life-long hearing loss when carriers of the variant are given certain antibiotics".

Genedrive said the test has the potential to save thousands of children from lifelong hearing loss, whilst providing a net positive financial outcome case to healthcare systems.

In 2021, 3.7 million babies were born in the US, with 11% born prematurely.

Chief Executive Officer David Budd said: "The US is a particularly attractive market for this unique test given the potential to save hundreds of individuals from life-long deafness and reduce litigation costs relating to the unwanted side effects from antibiotic use on those carrying the gene variant."

By Xindi Wei; xindiwei@alliancenews.com

Copyright 2022 Alliance News Limited. All Rights Reserved.

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Securities Mentioned in Article

Security Name Price Change (%) Morningstar
Rating
Genedrive PLC 1.83 GBX -8.66 -

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