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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.’
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