US FDA pre-submission for Genedrive MT-RNR1 kit25 Oct 2022 19:27
Wed, 5th Oct 2022 07:00
RNS Number : 7594B
'Genedrive plc (AIM: GDR), the near patient molecular diagnostics company, announces that it has commenced engagement with the U.S. Food and Drug Administration ("FDA") to progress the regulatory approval of the Genedrive® MT-RNR1 ID Kit into the USA.
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. Those that carry the variant can then be given alternative treatments following detection of the variant by the Genedrive® MT-RNR1 test. It 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 USA, with 10.5% born prematurely. It was estimated that malpractice litigation settlements in cases related to deafness caused by the use of aminoglycosides average over US$1.1 million per case, further adding to the positive health economic case of providing accurate and timely testing to reduce unwanted side effects of gentamicin usage.'
Just thought we could start a new Subject/ Title and shake off all that childish 'he said, she said' nonsense that seems entrenched on this board ;-)
Can those responsible consider that some investors don't see any value in endless and pointless accusations (obviously speaking for myself but feel sure there are others like me;)
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