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scaredy - the data sheet on innova has been known for some time and I think the govmt accept the actual figures are different, and different again with untrained public self testing and likely different again when used AN. But it is galling that companies are being allowed to make claims about their accuracy that have no bearing to the accuracy levels that they actually have used in the real world by trained and, most especially untrained, users. I imagine that these sorts of claims are probably part of what got innova into trouble - and relatedly the fact that unless it is being used naso on symptomatic with professional supervision the company does not actually have its own relevant validation. Sure PHE have data but the authorities of other countries should question whether it is appropriate to rely on that.
And Innova allowed the use of frozen samples
How long does it take to correct a wrong?? I am hoping that the cream will rise to the top. I have not sold out .. I am waiting for Avacta to turn it around... and/or sell stuff to Europe/US or whoever ...
I’m no fan of the EU, but in this precise moment in time, they seem to care much more about their citizens that the UK gov cares about us.
I still think it significant that AS said that we were “engaged with” the Porton Down procurement process, rather than “engaged in” it. I take that to mean that they are involved with making it fit for purpose.
What makes you think Europe will be any better than the Uk gov, especially after Brexit.
It’s funny how people in here expects the gov to do the right thing. This is the most corrupt government in the western world, unless avacta has got an envelope full of cash for the tories, there is no contract coming our way. We are much better off focusing on Europe, Asia and airlines.
Good observation seethreeipo !!
more to the point....if Avacta were to bad mouth Porton down and then be approved, they would be effectively bad mouthing their own success........it's all starting to add up!
I think it's very interesting that Avacta weren't included in that article. The telegraph definitely know about Avacta, it's been everywhere and they're far more likely to know about them than some of the smaller organisations mentioned. This leads me to think that Avacta were approached for comment and they declined, which then leads me to think that they really are very close with Porton and don't want to rock the boat.
Can't make this crap up, the government needs to answer to the public, somebody needs to be held accountable. This make me angry. 3-4billion pound contracts on tests that are not fit for purpose.
Scarey.. please send it to Julia Bradshaw at the Telegraph...
Makes my blood boil this scandal. Speaking of which:
Just looking through Innova's data sheet for research purposes :-)
Found what I was looking for:
"14. 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."
So, we spend £3bn-£4bn on a test never evaluated on asymptomatic individuals to weed out asymptomatic individuals.
Makes perfect sense, hey.
https://cdn.website-editor.net/6f54caea7c6f4adfba8399428f3c0b0c/files/uploaded/Innova-SARS-Cov-2-Antigen-test-IFU.pdf
Thanks for posting. Shocking stuff really given public health is at risk and better tests are available. It’s ridiculous that they have engaged with the U.K. diagnostics industry, they’ve responded - quite often via their own pockets - and since been shoved aside for cheap imports
Scardey, thanks for that posting that, a good read. Enlightening and frightening in equal measure.
The exposure of this cluster eff is starting to gain traction now. (Not least due to the efforts of some of the stalwarts on this BB.) I can imagine a few bods in Whitehall and Porton Down are already getting twitchy, prepping their cover stories for when it hits the fan.
Wish Avacta would publish the performance of our test v Innova’s in the CV. Start throwing some mud around, playing it nice when the game is bent gets you nowhere.
Excellent - and very damning. That should ruffle some feathers at PHE and Porton Down. And so nice to see a journalist actually investigating this at long last!
4.
“None of it makes sense and there are holes all over the place. We need more oversight, scrutiny, transparency around the evaluation process, around the protocols around the process and how the tests are procured. Trouble is, I think the Government is scared of what it might find.”
A Department for Health and Social Care spokesman said: “Covid tests used by the UK Government go through a rigorous laboratory-based evaluation at Porton Down by a joint PHE and University of Oxford team.
“We have published multiple evaluations of lateral flow devices, and other Covid tests, and will continue to do so to ensure our approach is as robust and transparent as possible.
“With one in three people with Covid showing no symptoms, and potentially spreading it without knowing, twice-weekly rapid tests are helping us find these cases and prevent the spread of the virus and its variants as society reopens.”
3.
Mologic was given nearly £1m by the Government last year to create a high-standard rapid lateral flow test but felt it had suddenly been “stonewalled” by PHE.
“PHE failed Mologic’s test, which other regulatory bodies have passed, while Innova’s [test] has passed. There is a disconnect there and there has to be accountability and transparency,” said Mr Evans.
“Lots of people in the industry are aware of there being an issue but there are very few people prepared to speak up as they feel they have something to lose taking on the Government.”
Boris Johnson visits the Mologic lab in Bedford in March 2020 CREDIT: Andrew Parsons / No 10 Downing Street
Tony Cooke, chief executive of Cambridge Clinical Laboratories, a specialist testing lab, said the whole process of evaluation and data-sharing was opaque: “It is inconsistent, not transparent, illogical and biased.”
Berwyn Clarke, another industry veteran and chairman of Iceni Diagnostics in Norwich, said his company had experienced similar problems with Porton Down.
“There were problems around the process; they really didn't know how to validate the test, they wanted to shortcut all the conventional routes," he said.
Iceni had spoken to PHE “quite productively for a long time” while it was developing its test, Mr Clarke said.
“We had months of discussion with DHSC about our dual flu and Covid test and they all thought it was a good idea. We went through our manufacturing run, sent them to Porton Down, they arrived in the morning and by 4pm they said they were not testing them. Why? Because they were a dual flu and Covid test and that was not in their brief,” he said.
Iceni pushed back and got MPs involved without success, Mr Clarke said. “There are all sorts of defects in the protocol they use at Porton Down. Whoever set the protocols in the place didn’t understand what they were doing. Someone should resign.”
He said other experienced test-makers had also, inexplicably, had their tests failed through the system. “I can’t remember the exact numbers but there was a really astronomical figure like 80pc of all the tests that went through Porton Down failed,” he claimed.
2.
David Evans, a well-respected figure who has worked in the diagnostics industry for 28 years in senior positions, said the FDA’s warning letter to Innova had “profound implications in the UK for the confidence and integrity the public can place in any diagnostic test and the MHRA should suspend the use of the Innova lateral flow test immediately pending further investigation”.
He said there needed to be complete transparency over the way any test was evaluated and what the data showed.
“The problem is there is absolutely no transparency on the evaluation process from PHE and Porton Down,” Mr Evans said.
“The data that sits behind Innova's test, for instance, should be subject to independent scrutiny given the performance of the test has been questioned. Otherwise this could seriously undermine confidence in public testing and could be dangerous if these tests produce false negative results.”
He also questioned why the Government was “throwing public money” at Innova to move manufacturing to Wales when a company called British Biocell International had a "30-year history of producing lateral flow devices and could do the job producing the same number of tests of higher quality”.
“We should be supporting indigenous UK companies,” Mr Evans argued. “I find the whole thing so strange. For the UK Government to fund a private equity company based in the states buying tests out of China when it could have supported in a far more substantial way the UK is reprehensible."
Bedford-based diagnostics company Mologic, for instance, whose lateral flow test has surpassed WHO standards, had its test failed by PHE at Porton Down several times, for reasons its chief executive has said he could not understand.
1.
Lateral flow test approval process must be reformed, industry leaders say
British companies that make the tests face difficulties winning approval through Public Health England’s process at Porton Down
ByJulia Bradshaw23 June 2021 • 11:37am
Leaders from the diagnostics testing industry have called for greater transparency of the evaluation procedure for lateral flow tests, arguing that the existing framework is biased, dangerous and not fit for purpose.
Britain is heavily dependent on fast-acting lateral flow tests made in China by US private-equity backed company Innova. The Government has spent billions buying these tests, but their performance has been questioned by many in the scientific community.
The test was dealt a blow earlier this month when the US Food and Drug Administration issued a warning letter to Innova, saying it should be "thrown in the trash".
Meanwhile, UK-based and other diagnostics players with tests that exceed even World Health Organization standards have failed to win approval through Public Health England’s (PHE) evaluation process at Porton Down.
You should be able to read the article and comments Agent B. You just need access to make a comment.
Onwards Avacta.
Is it possible to paste the article (and comments) for those who don’t have access please?
Me too. Can everyone put pressure on the Telegraph? Can't hurt.
https://www.telegraph.co.uk/business/2021/06/23/lateral-flow-test-approval-process-must-reformed-industry-leaders/
Just posted a response as many others have mentioning Avacta.
https://www.telegraph.co.uk/business/2021/06/23/lateral-flow-test-approval-process-must-reformed-industry-leaders/