RE: Clinical Validation Q416 Oct 2020 22:36
And more recently:
Q3: In relation to the COVID testing developments, are you receiving any support from the government at all?
A3: I’ve been asked that a lot and I can’t talk about the interactions we’re having with the government in any detail of course but what I will say is I’m very pleased there’s now a detailed dialogue which is very helpful in guiding our developments so that we can directly address the national requirements, but I can’t really say more.
Q4: I think you answered this earlier, but the COVID-19 rapid antigen test, when will that be available?
A4: So, I think as everyone knows we’re in the process of technology transfer and manufacturing scale up which is being carried out by BBI Solutions, one of our manufacturing partners and Cytiva. That is very much a development process, developing large scale robust manufacturing processes and, as I’ve said a number of times, the key milestone that we need to get to is the pilot batch of test devices. At that time, when we have that pilot batch and we’ve gone through that development process, we’ll be able to get a much clearer timeline to product launch.
It’s essential that that manufacturing process development is done properly because it’s a significant de-risking step, rushing it and ended up with a process that isn’t robust is a mistake and it simply pushes the risks down the line to the clinical validation, which I’m not prepared to allow.
So, we expect to carry out the clinical validation in Q4, as I said, and as soon as we have that pilot batch, I will be able to give a much clearer timeline through that clinical validation, CE marking and product launch.
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