The Genedrive® MT-RNR1 kit has been used in the NHS14 Oct 2024 15:35
Since about April 2023. I understand the results of each test have to be confirmed by an NHS lab. So it is now October 2024 over 1 and a half YEARS later. They must have loads of test results by now, all checked by the NHS labs. This is why I believe the FDA clearance could be a lot further down the line than some people think.
RNS 31 Mar 2023
"A pre-submission (Pre-Sub) was filed with the FDA to agree the regulatory approval process of the Genedrive® MT-RNR1 ID Kit into the USA. The Pre-Sub process allows the Company an opportunity to clarify its testing and validation approach, confirm the appropriate regulatory application pathway, which are uncertain given that there is no directly comparable test in the market. The Company is in ongoing dialogue still with the FDA to ascertain the requirements, and consequently the funding estimate that would be required to conduct and manage the evidence generation and submission process.".
RNS 15 Jul 2024
"genedrive plc (AIM: GDR), the point-of-care pharmacogenetic testing company, is pleased to announce that it has received Breakthrough Device Designation from the U.S. Food and Drug Administration ("FDA") for the Genedrive® MT-RNR1 ID Kit.".
"Together with our in-place partnership with a multi-state physician led clinical partner with neonatal services expertise covering the majority of U.S. states we look forward to affordable, collaborative and timely progress through the FDA De novo process".".
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