REALLY EXCITING NEWS (albeit a bit weird in places...!)16 Sep 2024 17:29
So, something weird but very exciting has happened today - Pockit Diagnostics (AKA Upfront Diagnostics) and their LVOne test are now appearing on the public MRHA Medical Devices Register.
https://pard.mhra.gov.uk/device-details/Multiple%20stroke%20(cerebral%20vascular%20accident)%20marker%20IVD%2C%20kit%2C%20rapid%20ICT%2C%20clinical%26%26IVD%20General
That's really important, because registration is mandatory before you can market a product in the UK, and you don't get registration (at least on the public register) without providing various information including copies of your conformity assessment certificates, ie UKCA, amongst other things. More details are here;
https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market#when-you-must-register
The weird thing is that the registration date is showing as 3/2/23. Now, I have checked that database daily for the last year (sad I know) and I assure you that today is the very first time the Pockit entry has appeared. I don't know why the registration date is showing as effective from 18 months ago, but surmise it might have something to do with when they first started clinical trials of the product in real world scenarios.
I strongly suspect that the registration listing has only now been published because LVOne has only just been awarded EN ISO 13485:2016 Quality Management System (QMS) certification, something I have no doubt we assisted with. And is it coincidental that that QMS certification closely followed our own excellent BSI audit results?
Whatever the case, Upfront now appear to have a UK patent, UKCA, permission to market in the UK, and participation in IDAP as an accelerator into the NHS. Oh, and to top it, this particular test (which we definitely make) involves two separate LFT's - double bubble for us if you like.
I can't see it being very long at all ow before we see this being sold into the NHS. As I posted earlier, the cost savings involved in early stroke diagnosis are just huge.
As I say, this is really exciting news for ABDX (and its shareholders) in my opinion.