RE: The board25 May 2021 12:26
"Hi Regulator..re Avacta.On 10th May they submitted their test to MHRA for CE approval and stated they expected to receive confirmation in "the coming days".They also stated,upon confirmation,that they would be able to 'immediately' supply their test to market.Assuming the approval is both forthcoming and imminent,and then Affidx is chosen as the sovereign test,pending TT ..couldn't we,then quite realistically,be mass producing Avacta's test in the next couple of weeks ?.maybe i'm missing something..."
They didn't submit their test to MHRA for CE approval - that's not how CE marking works. CE marks are applied by either a notified body or a manufacturer when there is evidence they meet the regulatory requirements. Once a CE mark is applied, an application for marketing authorisation is submitted to the competent authority (in this case MHRA). If this is granted, then they can market for professional use in the UK.
To be included in the sovereign test programme, Avacta will need to submit the test for evaluation by PHE Porton Down. This takes a number of months to complete.
I don't believe that there will be a single 'sovereign test' but a range of tests, manufactured by a range of manufacturers.