RE: Share Price3 Jan 2024 20:11
Greend100
I'm fairly sure other labs would still need their own validation for an LDT, because of this part:
"This analytical validation is limited to the specific conditions, staff, equipment and patient population of the particular laboratory, so the findings of these laboratory-specific analytical validation are not meaningful outside of the laboratory that did the analysis"
But clearly with the experience of one lab under the belt, others should be easier and confidence of successful validation very high.
Main thing for me is that success at Corepath de-risks everything on commercialisation. We already know the test works from previous trials, but this is the first test on a platform designed for commercial scale.
This works, then we know revenue will follow, initially from wider rollout across the globe of similar lab acredited tests, or through the LFT style test - an RNS saying we have achieved that would have ciz multbag again on top of the first multibag! Assuming we aren't bought out before then of course.
Of course, all this starts with the test being validated analytically. But I'd be very surprised if they had moved to Corepath trials without high expectations around what those would likely achieve.