OK I will start - My understanding and expectations from presentations and announcements is -
- We can expect over the next couple of months that they have completed all the necessary number of samples to validate further the current results and be in a position to have a laboratory approved test.
- Next step and maybe in the background already they will select and contract with commercial partners to commence commercialisation and further work for full approval as a fully commercialised patient test. This initial step will lead to first commercial revenues, I don’t think they have indicated a number but maybe I missed it, my thoughts are probably relatively small for first 12 months and big uptick will come after full patient test approval.
- They already have a lab partner in the US Research DX who is doing the required number of samples. My interpretation of the projects they have run is in the diagnostic space they work with expert partners both R&D and commercialisation, in the Exo space they work mainly internally but use partners to commercialise .
- Steps in approvals in the US is usually 510k then full approval but with current results 510K and research use could still be considerable with the right partners.
- Current other unknown is given results incorporating SB2M into other’s existing kits ie Roche where references to improving their kit’s performance has been disclosed-could be things happening in the background??
- Current results relative to what’s in the market would indicate a high chance of success and I haven’t heard of any impediments beyond the usual risks in R&D and commercialisation.
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