RE: Lateral Flow Antigen Test - Mologic9 Sep 2020 14:11
We know the process is as follows:
R&D
Prototype
Initial evaluation
Continued performance enhancement
Design Freeze
Clinical Validation
CE Mark
Manufacturing scale up and tech transfer
PHE/MHRA validation
Approval for Professionals Use
Commercial roll out for professional use
Self test study and validation
Self test approval
Commercial roll out for individual use
I would assume a self test antigen test will have to go through the same process. As far as we know, AVCT have not even started clinical validation yet and appear to be at the initial validation phase before design freeze. With Mologic, the first we will hear going by the Antibody test, is when Mologic CE mark the test. The fact that it has been used in a live trial is a good indicator of progress.