Hi RandomGuy01, thanks for posting the links.
The studies you've pointed out is part of phase 3B of the UK procurement process. Specifically, it is Raptor-C19 (GP surgeries and community hubs), and note that in phase 3B, there is also Falcon-C19 (hospitals and testing centres) and Condor-CH (care homes). I don't believe ADO would have reached stage 3B by now, as there are many steps beforehand and its too early to anticipate that they would be part of it now. Here is the breakdown of different phase 3B clinical evaluations and the progress report:
https://www.condor-platform.org/condor_workstreamshttps://www.condor-platform.org/condor-activity-reportSo, let's go back to the UK procurement process. The applicant must submit the application dossier (ideally after receiving the CE mark) (Stage 1). So this is April 12 for ADO (8 days ago). Then it will take the Technologies Validation Group (TVG) minimum 2 weeks to evaluate the application dossier and revert to the test developer (stage 2 and 3) and potentially recommend to the DHSC for technical validation (stage 4).
https://www.gov.uk/government/publications/assessment-and-procurement-of-coronavirus-covid-19-tests/coronavirus-covid-19-serology-and-viral-detection-testing-uk-procurement-overviewNow, once we reach stage 4 of the validation process, this will be broken down into different phases.
https://www.gov.uk/government/publications/assessment-and-procurement-of-coronavirus-covid-19-tests/protocol-for-evaluation-of-rapid-diagnostic-assays-for-specific-sars-cov-2-antigens-lateral-flow-devicesPhase 1 - DHSC will identify the product pipeline based on TVG assessments.
Phase 2 - 500 kits will be sent to PHE Porton Down for clinical evaluation. You can see tests that have successfully passed this phase here:
https://www.gov.uk/government/publications/assessment-and-procurement-of-coronavirus-covid-19-tests/outcome-of-the-evaluation-of-rapid-diagnostic-assays-for-specific-sars-cov-2-antigens-lateral-flow-devicesSo we will be interested to see ADO on this list first before Eugeni will appear in Phase 3 trials.
Phase 3 - Phase 3B trials you have shared links with us and I've discussed above. At some stage, if you are interested in the progress, It is possible to request information from PHE on the progress of the trials:
https://www.whatdotheyknow.com/request/which_lateral_flow_tests_have_pa_2https://www.whatdotheyknow.com/request/719194/response/1725713/attach/2/2494%20FOI%20List%20of%20all%20Lateral%20Flow%20Covid%2019%20Antigen%20tests.pdf?cookie_passthrough=1The above tells you as of 16 February 2021, how many tests and when they have passed phase 3A trials. I imagine, if you are very curious, you can make the same request for Phase 3B trials when the time is right.
As you can see from your own links that the UK Government expects to run phase 3B evaluations until 03 October 2022. This means that the UK Government does not expect to stop testing and procuring new tests until that date. It does not mean that one test will be studied for that long. So if ADO is tested in the next couple of months, it is by no means too late, especially given the fact that we are aware of the tests that passed phase 3 trials and their overall clinical performance and manufacturing capacity of these companies. Note that Abbott and SD Biosensor have contracts to supply to the EU too.
By sharing the information about the UK procurement process, I am highlighting the fact that our test meets their criteria and it seems to me that the management is also gearing towards securing this procurement given that the number of samples they tested meets TPP and they decided to accelerate the saliva trials and carry it out in the UK. We do not have details on such trials yet, but I am happy to wait few more weeks for their results and details. The management has been delivering and the more I understand the requirements, the more I am of the opinion that the management is choosing the most appropriate route to secure procurements/contracts as opposed to the fastest route to make announcements to the market.
All IMO and DYOR.
