RE: Schrödinger's conspiracy theoryToday 22:13
Fastfood,
I have no desire to turn this bb into a slanging match, so i will respond to your post, and hope we can draw a line under it and get back to genuine posting for the benefit of all.
Your comment was disingenuous to say the least.
I did NOT say that the NHS would want it inside a 2 year timeline. I very clearly said i EXPECT this to be a lot sooner than 2 years. I have the same control over times frame as you. - NONE.
Yes, i did expect it to be sooner, as i think most would freely admit they did, but given we may have been behind schedule, and i think i remember in a publication some mention of the pandemic having an effect, then this would reasonably be a factor, but not an excuse.
With regard to NHS, this is a class IIb IVD device.
It requires registration with MHRA. This can only take place AFTER it has been certified by a UK certified body (UKCA now, following Brexit)
It cannot be certified yet, as it has not been validated as a test kit. Hence there is nothing for the NHS to be able to use.
That is exactly the reason that it being developed via Corepath in USA. They are a CLIA accredited laboratory that can do all the validation, and provide all the regulatory requirements under an LDT.
An LDT is the quickest route to get our test commercialised.
That is EXACTLY the process that the Galleri test has gone through.
The above is also why China can't be progressed to commercialisation yet. The reagents/Mabs are the ones CIZ will provide to the China partners when they have been validated.
Neil