Genedrive PLC, the near patient molecular diagnostics company, has started talks with the US Food and Drug Administration (FDA) to progress the regulatory approval of the Genedrive MT-RNR1 ID kit into the US.
The company said the Genedrive 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.
It has the potential to save thousands of children from lifelong hearing loss, whilst providing a net positive financial outcome case to healthcare systems, the company said.
Genedrive has submitted via the FDA's pre-submission process because there is no exact comparable test in the market already.
This process allows the company an opportunity to clarify its testing and validation approach, confirm the appropriate regulatory application pathway and gain additional procedural feedback from the FDA with the aim of making the final submission process more efficient.
David Budd, CEO of Genedrive, 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.”
Shares in Genedrive soared 25% on the news.