Ann: Test Platform and COVID-19 Test receive CE Mark approval, page-59

While researching the UK regulatory market last week because someone posted about another test from the UK, I have found information that I am increasingly more positive about ADO's prospect.

Now that ADO's test has CE mark, it can apply for procurement from the UK's government (something I sense Derek was hinting at). At the moment, more than "100,000 businesses in England have registered their interest to providerapid tests to their employees, and the offer of free testing is being expandedto companies with over 10 workers where on-site testing is impossible."

The UK's government website provides details on the procurement paths and the number of companies that succeeded so far.
https://www.gov.uk/government/publications/assessment-and-procurement-of-coronavirus-covid-19-tests/coronavirus-covid-19-serology-and-viral-detection-testing-uk-procurement-overview

The technical validation processinvolves 6 keys steps:

1. Register through the online form: Antigen test manufacturers are invited tocomplete the onlineform for each test they want to supply.The form captures the main clinical and commercial information required totriage the large volume of offers received.

2. Triage of online form by scientific advisor: supporting documents are reviewedby a scientific advisor to categorise the type of test and refer it throughappropriate validation and evaluation route.

3. Initialreview by Scientific Expert Panel:The online form and supporting documents areinitially reviewed by a member of the Scientific Expert Group. TheScientific Expert Group is made up experts in technologies, viral testing andinfectious disease. This a subgroup of the Technologies Validation Group (TVG).The Group undertakes a detailed assessment of the information on the solutionsand technologies that have been submitted. Companies should expect to receiveany outcome from the Scientific Expert Group within 2 weeks. This may be longersubject to the volume of offers that we are reviewing.

4. Technical and in-service evaluation: Offers that are deemed by the ScientificExpert Group to have met the relevant TPP and align to the current needs of theNational Test and Trace programme will be progressed for technical validationand in-service evaluation. Manufacturers will be contacted and invited to takepart in further technical validation and/or in-service evaluation. As part ofthe technical validation process and/or in-service evaluation manufacturerswill be matched with a validation laboratory.

5. Decision by the Technical Validation Group: The technical validation includes,but is not limited to, a bio-safety assessment, lower dynamic range analysisand an initial test accuracy assessment. The information generated at thisstage will be compared to the TPP. Products that meet the technical validationcriteria may progress to an in-service evaluation. The outcome of the technicalvalidation and in-service evaluation will be reviewed by the TechnicalValidation Group (TVG).

6. Procurement discussion: Forthose technologies recommended by the TVG that suit use cases with unmet demand,the DHSC commercial team will invite those developers or suppliers to take partin a competitive procurement either via mini-competition or via appropriateframeworks.

So far, only one antigen test has been successful, the LumiraDx SARS-CoV-2 antigen test. Interestingly, when you look at the company's website, they claim the test to have 97.5% sensitivity and 97.7% specificity. On the UK government's website however, after going through the validation, the test is only 83.8 % sensitive and 98.7% specific and its LOD turned out to be ~62500 copies/ml.

Given that ADO's test is 97.3% senstive and 99.6% specific with data backed by Doherty Institute and not internal/manufacturer-carried studies; and with the LOD now confirmed at ~300 copies/ml, ADO stand a great chance at winning the procurement from the UK's government.

And if anyone thinks that competition can just declare an effective test and pose a competitive threat, see the list and reasons for failure to successful procurement below (only 14 out of 139 applications succeeded). A lot of it is because the supplier was not able to provide data that the TVG reguested.
https://www.gov.uk/government/publications/assessment-and-procurement-of-coronavirus-covid-19-tests/products-in-the-pipeline-tvg-validation-concluded-or-paused

I was wondering why ADO would move the clinical trials early and to the UK is the Doherty Institute's data is enough to sell (to private market) within the EU once the CE mark is achieved. The hint probably is in the protocol to evaluate the test for procurement by the UK government (for step 4 above). It needs a minimum of 500 kits will be shipped for Phase 2 testing and 4000 kits for Phase 3 that 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.

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-devices

And here are some tests that have gone through this validation and which I have made comparisons to in my previous posts.
https://www.gov.uk/government/publications/assessment-and-procurement-of-coronavirus-covid-19-tests/lateral-flow-devices-results

A lot to look forward to in the next coming months. IMO