Clinical validation supported by CONDOR4 Oct 2020 10:44
The weight of evidence suggests validation is a given. The test works, we've been told this numerous times it uses the same Affimers as the ELISA and BAMS tests.
Challenge is manufacturing as stated in the latest presentation we will never make enough for demand, what a position to be in.
-Avacta is expanding its inhouse Affimer production facilities and putting in place very large scale contract manufacturing partners; Affimer and nor will nitrocellulose strip. Avacta supply will not be a limiting factor
-has partnered with BBI Solutions and Abingdon Health to date, who can manufacture several millions of lateral flow test strips per month.
-UK strip manufacturing capacity needs to be scaled rapidly to address the anticipated volume requirements and additional capacity is being put in place overseas.
-Kit assembly is a challenge and partners in the UK have been identified and additional resources overseas are being put in place.
-Detailed discussions with regulatory authorities, governments and healthcare providers are ongoing but are strictly confidential.