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From: **************************
Sent: 25 June 2021 08:04
To: 'julia.bradshaw@telegraph.co.uk'
Subject: UK Lateral flow test approval process
Dear Ms. Bradshaw
After reading your excellent article published in the Telegraph on Wednesday regarding the UK Lateral flow test approval process, I was wondering if you are aware that there is newly proposed government legislation (1) that sets out laws to validate the accuracy of new and existing private COVID-19 tests. On studying this proposed legislation, I was dismayed to see that a ‘free pass’ will be been given to the Innova test, such that, they will be exempt from this new validation process on the basis that they have achieved an ‘equivalent’ validation at the Porton Down facility. In my letter, I argue that Innova’s Porton Down validation is now redundant (see letter below) and should not be used as a measure of equivalence.
I am hoping to persuade my local MP to table an amendment to the proposed legislation to remove this ‘free pass’ for Innova. As somebody who has an interest in the Innova story, I was wondering if you might be able to assist in any way. Perhaps you may know of an MP who might be interested in taking up this cause, or perhaps you might consider publishing my letter as an open letter to MP’s in general.
As a UK taxpayer and supporter of the UK diagnostics industry, I am appalled at treatment of cutting edge UK diagnostic companies such as Mologic, Avacta, Abingdon and Omega, compared to the ‘red carpet’ treatment afforded to Innova.
I very much hope you can assist in this matter. Thank you in advance.
Kind regards
(Will publish my letter to local MP shortly)
1/2
Dear [Your Local MP]
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.
2/2
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).
Kind regards
(1) Government proposed law to validate accuracy of private COVID-19 tests.
https://www.gov.uk/government/news/government-sets-out-laws-to-validate-accuracy-of-private-covid-19-tests
(2) PHE Porton Down time-limited SARS-CoV-2 test development and evaluation programme.
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
(3) Innova Porton Down Phase 4 evaluation.
https://www.ox.ac.uk/sites/files/oxford/media_wysiwyg/UK%20evaluation_PHE%20Porton%20Down%20%20University%20of%20Oxford_final.pdf
(4) Innova’s IFU (Instructions for Use).
https://cdn.website-editor.net/6f54caea7c6f4adfba8399428f3c0b0c/files/uploaded/Innova-SARS-Cov-2-Antigen-test-IFU.pdf
(5) DHSA become the legal manufacturer of the Innova test.
https://www.dailymail.co.uk/news/article-9127345/UK-coronavirus-Department-Health-rebranding-professional-use-kit-self-test.html
(6) The desktop review guidance document.
https://www.gov.uk/government/publications/assessment-and-procurement-of-coronavirus-covid-19-tests/private-testing-desktop-review-stage-2-operating-process-for-sars-cov-2-tests#clinical-performance
(7) Innova described as ‘not fit for purpose’ by the US FDA.
https://www.fda.gov/medical-devices/safety-communications/stop-using-innova-sars-cov-2-antigen-rapid-qualitative-test-fda-safety-communication
(8) UK Government £3 billion Innova order history:
https://bidstats.uk/tenders/?q=%22Innova+medical+group%22#753139711-737214508-57
Thanks AgentB - used some of your links.
@scaredy.
Absolutely fantastic synopsis and letter.
Could not have put it any better.
Brilliant.
Fingers crossed Scardey...looks like Hand.... is going to get a pasting...wot a pl..nker.
Kaleb would do a far better job than Hand.... and he'd see through all the PD/Innova BS...
Scardey_cat,
Thanks for your excellent letter to Ms Bradshaw. I recommend you send it to MPs Steve Baker and Mark Harper as they may actually take it up with the Government and DHSC . Will you do that or, could I copy it to them?
Zendog
Sure, you do that @Zendog. Suggest everyone sends to their local MP.
Even if they don't take up the cause, at least you will make them aware of the situation.
I'm sending it everywhere, starting with Ian Hislop, Sonia Elijah etc. etc.
This goes beyond my investment in Avacta.
Can't remember being so angry about anything in my life.
@Scardey_cat
Great that you have sent a very good letter to Julie Bradshaw, but as regards sending to MP's, I think a waste of time. I agree with Zendog that Steve Baker and some others do the work they are paid to do, but the rest of the s**tshow,
As the royal family don't say, - Never address a complain(t), never explain!
I hope someone who is a constituent of Kier Starmer or Jon Ashworth sends them a copy - useful for pmq's imv.
Scardey_cat, That's a stunning, classy letter you've written there, well done. I like that you don't mention Avacta as it may have come across as a bit prejudised.
I'll certainly be copying and pasting, word for word, and forwarding to anybody of influence I can think of.
You're one of the very best posters, in my opinion, on this board. Keep it up my friend.
Cheers
JT
Scardey, how about posting this on ODX as well? They seem to appreciate cross-board co-operation.
Yeh, I'll do that AgentB. Will send an accompanying English dictionary with it - you know what that lot are like :-)
From: SoniaElijah [mailto:SoniaElijah@protonmail.com]
Sent: 25 June 2021 10:10
To: ************
Subject: RE: The Innova tests: another Covid scandal in the making?
Thank you Martin for your email. It's such a scandal regarding this 'free pass' for Innova. I will forward this on to my editor and discuss with her. I think your letter to MP is very good and should be used as a template.
Thumbs up to Julie....and Scardey...
Scardey...will you be sending a copy to Avacta too?
Thanks @Bella. Yes, I'll send them a copy. Any other recipient suggestions welcome.
Just sent it to my bezza, Christian @ Medusa. Asked him if he could forward it on to Sir Al - you never know.
Scardey I forwarded your letter to MP's with List of Links and received this reply from Owen Patersons office by return:
'Thank you for your email. Mr Paterson will write to the Minister about this and I will be in touch as soon as I have received a response.
Best wishes,
Claire
Mrs Claire Ayres
Senior Parliamentary Assistant to the Rt Hon Owen Paterson MP'
Many thanks MrA...correction made.
I knew you'd spot something :-)
Thanks MrA, very helpful.
I actually had you down as an English teacher, after seeing your suggested 'edits' to AgentB's fine effort.
My partner is also an English teacher :-)
Or a contract lawyer?
Good stuff scardey. I recommend you also write to Jeremy Hunt MP, chair of the Heath and Social Care Select Committee.
https://members.parliament.uk/member/1572/contact
Thanks @mstar. Sent to Jeremy Hunt (with MrA's corrections :-))
However, got bounced back:
"Parliamentary protocol states that MPs can only respond to correspondence from their constituents"
So, somebody in his constituency needs to send it.