RE: FDA application for MT-RNR1 in the USA. To me this is key. How much31 Oct 2025 13:37
TLDR: Submission now estimated end 2026, once clinical data from US partner is complete, so authorisation presumably early 2027 - if FDA is happy!
EC you don't have to ask Gino - the info is already out there, so you can just ask Google to summarise or re-read the RNSs especially the updates sections of 23/9 Placing Proposal. E.g. the AI response it's just given me to "What are Genedrive doing to obtain FDA authorisation for its MT-RNR1 test?"
is ...
"Genedrive is working to obtain FDA authorisation for its MT-RNR1 test by pursuing the De Novo regulatory pathway and conducting necessary clinical trials in the US.
Key actions include:
Breakthrough Device Designation: Genedrive has received "Breakthrough Device Designation" from the FDA for the MT-RNR1 test, which is intended to help expedite its development and the subsequent review process.
De Novo Pathway: Because no equivalent (predicate) device currently exists on the US market, Genedrive is seeking authorization through the De Novo classification process, a risk-based pathway for novel low-to-moderate risk devices.
Clinical Trials: Genedrive has entered into a clinical trial agreement with a leading multi-state physician organization in the US to conduct the clinical studies required to support the De Novo submission.
Pre-Submission Process: The company initiated the FDA's Pre-Submission process to get early feedback on its testing and validation approach and to confirm the appropriate regulatory pathway, with the goal of making the final submission more efficient.
Funding: Securing sufficient funding has been identified as a key factor in progressing the required clinical studies and the overall FDA application process.
The clinical performance data generated from the ongoing UK real-world evidence programs (such as the PALOH-UK study) are also expected to contribute to the data requirements for the FDA submission. "
As alluded to, in the above, it's easy to see why lack of funding to get the US clinical studies done might have been slowing things down, in addition to the fact that it was stated the FDA are asking for additional information, hence why the expected timeline has been put back to 2027 as Roger pointed out earlier today.
i.e. in the 23/9 RNS it refers to "dialogue with the FDA ongoing on evidence requirements" and submission estimated for the end of 2026 under the de novo route.
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