Again, it may be speculation, but I like to play detective games. Regarding the procurement in the UK and saliva validation, ADO has not named the lab that is carrying out the work, but was very forthcoming to name VIDRL. I actually emailed the company to ask about the name of the lab (thinking it would not be price sensitive) and have not received an answer from them yet. I have also asked them whether it was a clinical study with lab samples or clinical trial and in the last announcement (that was released after my email to them) they have clarified as follows but not named the lab:
"
The laboratory validation of the saliva samples is currently underway. Pending analysis and results of the saliva samples, an updated CE regulatory submission will be made to amend the Instruction For Use (IFU) of the current EuGeni SARS-CoV-2 ART to include oral saliva sampling. The test and all components remain the same. AnteoTech remains on track to submit the update to the CE Mark in June 2021, pending results."
I also noticed the following from PHE:
"
PHE’s name and logo are proprietary to PHE and cannot be used for the purpose of commercial promotion of any particular product.The terms and conditions under which PHE’s evaluations are carried out expressly prohibits any such use which could be a breach of contract in relation to PHE and may be misleading in relation to potential customers."
https://www.gov.uk/government/publications/position-statement-regarding-covid-19-tests-evaluated-by-phe/position-statement-regarding-covid-19-tests-evaluated-by-pheSo it would then make sense that ADO is using the equivalent of VIDRL to test in the UK and in this case cannot disclose the name in fear of breaching contractual terms. Anyways, just a speculation, but otherwise I see no reason why ADO did not hesitate to name VIDRL or institute in India but cannot name the current lab in the UK.
Then in terms of manufacturing, DT did mention that they are in talks on manufacturing in the UK and Operon deal seem to exclude the UK. I just noticed this footnote at the bottom of the UK Government's website:
The technical validation process involves 6 keys steps:
1. Register through the online form
2. Triage of online form by scientific advisor
3. Initial review by Scientific Expert Panel
4. Technical and in-service evaluation
5. Decision by the Technical Validation Group
6. Procurement discussion
[footnote 1]
1. Commercial and supply chain conversations will commence earlier in the process and happen in parallel through the relevant process. ↩https://www.gov.uk/government/publications/assessment-and-procurement-of-coronavirus-covid-19-tests/coronavirus-covid-19-serology-and-viral-detection-testing-uk-procurement-overviewSo the conversations on manufacturing will happen concurrently with the validation process. And here is the link to the manufacturers:
https://www.gov.uk/government/news/uk-government-announces-partnership-with-british-rapid-test-manufacturers
So now back to the TPP:
Now after we have the IFU of Axxin test, we know that it can be portable (even handheld) and barcode system possible and battery charged. So this further meets the TPP requirements that we didn't know about.
The only parameters that I see as desirable that we do not meet is the semi-quantitative output and the need for a reader, but it meets TPP acceptable criteria here. Apart from that, ADO's test would tick most desirable boxes after the saliva validation test results are out.
https://www.axxin.com/files/D003808v8%20Brochure%20Axxin%20Rapid%20Diagnostics%20AX-2X.pdfhttps://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/895745/TPP_Point_of_Care_SARS-CoV-2_Detection_Tests.pdfI already mentioned the coincidence with the number of samples required, didn't I?
Based on past behaviour, ADO was not comfortable with VIDRL's results for saliva but was comfortable enough to go ahead with the nasal swabs and they turned out quite high. Given DT's confidence with this saliva tests, I have an inkling that it will be positive too. Also from the protocol page on phase 3, it states the following:
"Only if the Oversight Group agrees that a product has passed phase 2 and 2A will it proceed to phase 3. DHSC will advise the relevant manufacturer accordingly and request them to ship at least 4,000 kits directly to PHE Porton Down.
Phase 3 will be carried out against a larger sample set, namely 1,000 true negatives and 200 true positives, which will be sourced by Oxford University Hospitals. The negatives will be fresh samples, transported within 48 hours, the positives will be frozen. This follows recent work at PHE Porton Down to support the development of this protocol which found there to be no discernible difference in performance when using frozen samples."This suggests that phase 3 is also a "
laboratory validation" for which a lot of sample test kits needed to be sent.
Also another thing that I haven't been able to answer is that if the tests needed to be shipped for evaluation in any other way, it looks like they would need to be registered on the MHRA website:
"
IVDs undergoing Performance Evaluation IVDs subject to new performance evaluation studies in the UK must be registered by the time the study commences (no grace period)
For existing ongoing performance evaluations (commenced before 31 December 2020), the grace period as per IVD classification can apply
Non-UK manufacturers conducting performance evaluation in the UK will require a UK Responsible Person or Northern Ireland-based Authorised Representative in order to register with us
For all performance evaluation studies we require a Declaration for Performance Evaluation - to UK MDR 2002 Regulation 43 Statement (Annex VIII of Directive 98/79/EC) or Part A of Annex XIII of EU regulation 2017/746"https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market#who-must-register
But the tests are not on the database of registered products but according to the announcement, they appear to have been shipped.
https://aic.mhra.gov.uk/era/pdr.nsf/device?openpage&start=6401&count=200
So either the kits with CE mark are exempted from this requirement, or if they are shipped at the request of the DHSC they are exempted from this requirement.
As usual, I might be biased and see all in our favour because I hold their shares, but I feel as if something is brewing. IMO and DYOR.
(20min delay)