RE: Progress of LFD6 Sep 2020 09:29
Bobd29 from what the 9th June Bams RNS says, it would seem CE/FDA will happen following validation so can assume its the same for LFT:
The next step in the development of the final product to run on the installed base of mass spectrometers in clinical laboratories around the world is to evaluate and optimise the BAMS assay using patient samples at laboratory sites in the UK and US which will be done imminently before moving to manufacturing, clinical validation to quantify the sensitivity and specificity and CE/FDA approval for professional use in the summer.
We also know from the most recent RNS that the expected demand for the LFT will be UK and elsewhere as the search for global partners continues. I agree, would be nice to learn more about global approvals although news of a new non UK manufacturing partner would make a great RNS :
Manufacturing capacity is therefore the key challenge that has to be met in achieving widespread roll-out of Avacta's saliva-based rapid antigen test. We therefore continue to actively seek additional manufacturing partners globally to be able to provide the volume of tests that will be required in the UK and elsewhere.