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Your Ref: EC13622 PO-1337759
Elliot Colburn MP
By email to: elliot.colburn.mp@parliament.uk
Dear Elliot,
From the Lord Bethell Parliamentary Under Secretary of State for Innovation
39 Victoria Street London SW1H 0EU
020 7210 4850
26 July 2021
Thank you for your correspondence of 15 June on behalf of one of your constituents, about the manufacturing of COVID-19 testing kits. I apologise for the delay in replying.
We are committed to boosting UK manufacturing and demonstrated this with the award of
a contract for 20 million devices to Derby-based test manufacturer SureScreen
Diagnostics. These lateral flow device (LFD)
tests
were the first British tests to be
validated in the laboratory by Public Health England (PHE).
Collaboration between industry and the Government continues to be a priority, and we are
hugely grateful to all the manufacturers and suppliers that have come forward to offer their
assistance in producing LFD tests.
The valuable partnerships being created with companies such as SureScreen Diagnostics are further contributing to the resilience of the UK, both through supporting the work of UK
diagnostics manufacturers and by harnessing the possibilities opened up by rapid regular
testing.
Our LFD Dynamic Purchasing System will diversify the supply of LFD tests through fair and transparent competition.
Exceptional Use
The joint PHE Porton Down and University of Oxford team has developed a rigorous validation approach, which can be found at www.gov.uk by searching for ‘protocol for evaluation of rapid diagnostic assays for specific SARS-CoV-2 antigens (lateral flow devices)’.
The current validation process consists of three phases of assessment of increasing stringency. Phase 3a is a validation against clinical samples. Successful completion of this final phase means a product has demonstrated suitable performance and is therefore eligible for procurement.
To be purchased by the department, LFD tests need to have been validated by PHE
Porton Down and must have regulatory approval in the form of either an
Authorisation (EUA) or a European Conformity (CE) mark. None of the products for self-
testing with Medicines and Healthcare products Regulatory Agency EUA approval or a CE
mark is currently manufactured in the UK.
A number of UK products have been through Porton Down validation and have passed
phase 3a validation. None of these has yet achieved regulatory approval to allow them to
be used in the settings we require. However, work is underway to secure regulatory
approval for the suppliers of these products, and we hope that this will be completed
successfully in the coming months.
I hope this reply is helpful.
LORD BETHELL
Furthermore, despite the Innova test being originally designed for ‘professional use’ (see Innova IFU (4) – “The SARS-CoV-2 Antigen Rapid Qualitative Test is intended for use by trained clinical laboratory personnel”), the DHSC have re-designated the scope of the test as one that can be self-administered (5) (where the person taking the test obtains their own sample - a.k.a. self-use). In another cavalier move, the DHSC have distributed the Innova test for the purpose of identifying asymptomatic individuals, which runs contrary to the following statement in the Innova IFU (4) – “The performance of this test has not been evaluated for use in patients without signs and symptoms of respiratory infection and performance may differ in asymptomatic individuals”.
By appointing themselves ‘judge and jury’ of the Innova test, the DHSC has allowed itself to make fundamental changes to the Innova test’s characteristics, implementing them without any follow up Porton Down assessment; changes that would inevitably have had a significant detrimental impact on the test’s already underwhelming performance. Notably, to date, the government have not seen fit to publicly assess the impact of these wholesale changes.
It can clearly be seen that the initial Porton Down assessment of the Innova test is for all intents and purposes redundant, given the elemental changes made to the test’s characteristics by the DHSC, since that initial assessment was made. To use this redundant Porton Down assessment as evidence of ‘equivalence’ to the newly proposed assessment criteria, can at best be described as fanciful and at worst criminally irresponsible.
In summary, I would kindly request that you table an amendment to the proposed new legislation that either removes this exemption clause entirely, or modifies the wording to a version similar to that shown below:
“Tests currently supplied to the NHS under DHSC procurement will be exempted in recognition of prior equivalent assessment, so long as the prior equivalent assessment used the same sampling method as that for which the test is currently (or, intended to be) purposed and that the test was assessed for self-use purposes.”
I have kept this communication as brief as possible, in order not to distract from it’s main objective, however, I would just add that the Innova test in question is the same test that has recently been described as ‘not fit for purpose’ by the US FDA (7) and a test that the UK Government have so far spent close to £3bn on (8).
Regards
Dear XXXXXXXX
I write to you in connection with the draft legislation recently published on the Gov.uk website headlined “Government sets out laws to validate accuracy of private COVID-19 tests” (1). Whilst I welcome the proposed legislation, which will in effect raise the standard of private Covid-19 tests available for sale in the UK, I object to a proposal to exempt certain tests from the new legislation where they are deemed to have already undergone equivalent assessment via the PHE Porton Down time-limited SARS-CoV-2 test development and evaluation programme (2). A description of the grounds for this exemption can be seen in the ‘Notes to Editors’ section of the publication document (1) identified above, and is worded as follows: “Tests currently supplied to the NHS under DHSC procurement will be exempted in recognition of prior equivalent assessment.”
The particular focus of my objection is the Innova SARS-CoV-2 Antigen Rapid Qualitative Test (‘the Innova Test’), that is currently being supplied free of charge by the DHSC to businesses and to the general public, and the fact that this test will in effect be given a ‘free pass’ under the proposed legislation, even though the assessment carried out on the Innova test at the Porton Down facility can in no way be described as an ‘equivalent assessment’ given the fundamental changes made to the test’s characteristics by the DHSC (see below) since that assessment was made.
The Innova test achieved a sensitivity rating of 57.5% in it’s Porton Down Phase 4 evaluation (3), a rating achieved when the test was administered by a trained member of the public – I use this particular figure as it is the closest comparator to the current self-use deployment of the test by the DHSC. This very modest rating was achieved using a combined nasopharyngeal / oropharyngeal sampling method in accordance with Innova’s IFU (Instructions for Use) (4) – the optimal sampling method for which the test was designed. By designating themselves as the legal manufacturer of the Innova Test(5), the DHSC have enabled themselves to somewhat bizarrely override the Innova IFU and now instruct that the anterior nasal sampling method (a less invasive method) can be used for the test.
The proposed legislation recommends that a desktop review (6) be undertaken of all COVID-19 tests placed on the UK market and defines a set of minimum standards that these tests should meet. The desktop review guidance document states that tests should achieve the following minimum sensitivity rating [Sensitivity with 95% two-sided confidence interval entirely above 60%]. The Innova test sensitivity rating achieved at Porton Down was [57.5%, 95% CI: 52.3-62.6%], which is below the minimum required standards. Indeed, there is now considerable doubt as to whether the Innova test is currently achieving even this very modest 57.5% sensitivity rating, given the sub-optimal sampling method now being used.
I Have email letter to My MP and this was his replySubject: Re: Cuurent Shambles with LFT (Case Ref: EC13622)
Dear Mr Brown,
Thank you for your further email on Lateral Flow Tests.
I have passed your further comments on and will be in touch again as soon as the DHSC Minister has provided a response.
With best wishes,
Elliot
Elliot Colburn MP
Conservative Member of Parliament for Carshalton and Wallington
House of Commons, London, SW1A 0AA
020 7219 5862
elliot.colburn.mp@parliament.uk
From my humble opinion , I gather that the hold up was solely based on Avacta making sure the product worked against all variants.
Which was a very shrewd idea by the company.
Yes as investors we may have wanted the product to be available earlier however with the knowledge we have now , we have more ammunition to tackle all variant worldwide.
Onwards and upwards.
Am I one of many in here whos looking at athe amount of share currentlyu being sold and the price is not being affected.
I know thats not all that should be factored in , but I am going to play golf and hopefully when i return in a few dyas....i may be able to take exteneded breaks based on the share price.
onwards and upwards Avacta