RE: Pilot project details17 Nov 2024 13:19
For the contrary, I have had a reply couple of months ago , not directly from GDR but from Walbrook . I did send a similar email and had few questions about patents .
“ Genedrive became aware of this a few months ago after this press release was released in the US, but there has been no additional information provided and all that is known is what is in the public domain. It’s worth noting that there are no publications relating to their device or test and their website does not provide any details of stage of progress or regulatory certification.
The genetic test itself isn’t patentable, but first mover advantage is key, as are all of the required regulatory certifications to permit use clinically.
In the UK, NICE have agreed that evidence supports that the Genedrive® MT-RNR1 ID Kit quickly and accurately identifies babies with the MT-RNR1 m.1555A>G variant, who may be at risk of hearing loss if given aminoglycoside antibiotics. Further evidence is being generated in partnership with the Manchester University NHS Foundation Trust and the Royal Sussex County Hospital, Brighton has adopted the Genedrive® MT-RNR1 ID Kit for routine use. The product is also being sold in France, Austria, Greece, Saudi Arabia, Turkey and the Netherlands.
In terms of the US, the Company is at advanced stages in agreeing a partnership with a key strategic USA-based Medical Group with broad coverage of neonatal intensive care units nationally to progress our aim of introduction of our MT-RNR1 point of care pharmacogenetic test to the USA (subject to regulatory approval). Genedrive expect that this partnership would provide a highly cost-effective pathway for the required regulatory studies for potentially attaining approval in the USA.”