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Very damning! It was very opaque- the evaluation process. As shareholders we have shared 3 different specifications for sensitivity thresholds so far. One of which was 'very good ' LOL! Which is what Innova achieved after the initial 84%.
Been a shambles. We should all write to our MPs. Still makes me laugh/cry. The EDSAB report. Two pages. With a paragraph response to 'What have we learnt?' That you can't use filter paper to separate antibodies from blood. Which came out, after 5pm in November and then disappeared from the PHE site. I will share a copy again if anyone wants to send it to their MP as an example of how it's been.
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
By
Julia Bradshaw
23 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.
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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.
Mologic was given nearly £1m by the Government last year to create a high-standard rapid lateral flow test but felt it had s