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Quite a few people responded to my reproduction of the Sunday Times article by saying "We already knew that." and it's true for members of this BB. However, my purpose was to make people aware that the Avacta situation is now getting wider publicity in a major national newspaper which not many will have access to because it is a subscription based model.
Simple as that.
The article is so long that it had to be divided into 3 parts which are in reverse order so scroll down to see the first one and then read next (part 2) Part 3 is the most recent post. I hope this makes sense.
Alex Sheppard, its chief executive, said: “The government strategy was to prioritise the availability of lateral flow testing no matter what given the pandemic. They ended up dropping their initial strategy of utilising the British diagnostic industry because they were able to procure a significant volume of tests from outside the UK. This is different to the vaccine strategy which was to invest in early opportunities with data.
“It is still critical that the government invests in onshoring testing capacity from a biosecurity perspective. The UK must have domestic diagnostic sources to protect us from future pandemics and health crises.”
Sheppard said he thought the reason some British producers had failed to have their tests approved was because they were using different technology. “A large number of antigen tests developed in the UK were all based on unique technology. The centralised assessment methodology used by the government tended to favour products that were made with more traditional methodology.”
The one British company which appears to have its test approved for NHS home use is SureScreen in Derby, which began manufacturing tests for universities and an announcement is expected this week on its expansion.
Neale Hanvey, the Alba Party MP for Kirkcaldy & Cowdenbeath, whose constituency is near the Omega factory, is angry that Chinese companies have been relied on while manufacturers such as Omega have not received orders. Hanvey has scheduled an adjournment debate in parliament on Wednesday over the government’s handling of Covid contracts.
The UKHSA said: “In building the largest diagnostic industry in UK history, we have delivered 400 million tests since the start of the pandemic, playing a vital role in tackling the spread of Covid-19.
“NHS Test and Trace has drawn on expertise from across the public and private sectors and all contracts are awarded in line with procurement regulations and transparency guidelines.
“SureScreen, a British manufacturer, has committed to supplying 20 million lateral flow tests.”
Article ends
Mologic threatened legal action, questioning Porton Down’s methods, but it does not appear to have followed through with a lawsuit. Visitect, a version of Mologic’s test made by Omega in Scotland, is already being supplied to clinics in Europe. To qualify for European CE marking, companies have to send performance data and supporting documents but there is no independent evaluation of the test.
The new review system by Porton Down, overseen by Oxford University, is unique to the UK.
Tim Peto, a professor of medicine at Oxford University, is on the committee that checks Porton Down’s assessments of tests. He said that companies were “whingeing” when their tests did not perform well enough. “Some of the English manufacturers are very unhappy their kits have failed and some of them think that they’ve been unfairly tested. I don’t know on what grounds they think it’s unfair other than it came out negative.”
He added: “It’s not red tape. We are failing ones that fall below the line and rational critics would say they aren’t good enough.”
Peto said he was not aware of any backlog beyond what might have built up over Christmas, adding: “I wonder whether [companies] have been rejected but aren’t saying.”
Commenting on the large orders placed with companies overseas, Peto said “there was a definite wish to find local manufacturers because of supply security” but Britain did not have a long track record of producing lateral flow tests in the way that other nations did. It is understood that about 160 lateral flow tests made around the world have been checked by the UK Health Security Agency (UKHSA) for sale in Britain but only 46 have been approved. A handful of these have since been approved for NHS distribution as home kits.
Peto said part of the reason so many tests were being rejected was because they were being brought to market far more quickly than usual. “Normally it takes five years for a company to make a kit that it puts to market and lots of work and version 2, 3, 4, 5 before it’s stable enough to use,” he said.
The main providers of NHS lateral flow tests for home use are the Chinese brands Orient Gene, made by Zhejiang Orient Gene Biotech, and FlowFlex, made by Acon Biotech. Chinese manufacturers have more experience in lateral flow testing and the ability to scale up production far beyond British companies.
The Cambridge and Yorkshire company Avacta had to suspend sales of its AffiDX antigen test in November because it had not yet passed the new CDTA checks despite being entered for it before a September deadline. It has yet to be given the go-ahead in Britain. It was the first UK-developed test to be CE certified for consumer self-testing last month but can only be sold abroad.
The Oxford-based health company Vatic has developed a rapid saliva test called KnowNow that it is manufacturing in Britain but has yet to have it approved by the UKHSA.
See part 3 in later post
First half of a transcript of today's Sunday Times article . The second part follows - paywall
Delays in approval mean UK lateral flow kits don’t pass the red-tape test
British devices are available in Europe but cannot be used here, while Chinese brands corner the market
Emily Dugan and Hugo Daniel
Sunday January 02 2022, 12.01am, The Sunday Times
Several British tests are certified for use in the EU but have not been approved for the UK
PHIL NOBLE/PA
British manufacturers of lateral flow tests are battling with the government after their kits failed to be cleared for use in this country, despite being available in Europe.
The government invested millions of pounds to create a home-grown testing industry but only one British producer has managed to make a rapid test that meets UK requirements.
Despite the aims of Operation Moonshot to build up world-leading production in the UK, the majority of NHS home antigen tests are now two brands imported from China.
There were serious supply problems over Christmas and new year as the government advised people to test before mixing. Those trying to get hold of devices from NHS online were met with error messages and pharmacies ran out of kits. The situation has prompted stockpiling and meant that privately bought tests have soared in price.
Several British companies developing tests are frustrated that despite being certified for use in Europe their tests have not passed new exacting checks for use in the UK.
Since November any Covid test to be used in the UK has to pass a new set of regulations called the Coronavirus Test Device Approvals (CTDA). Several British manufacturers who sent their tests off in time for a September deadline say they have yet to have them approved for distribution in the UK.
Now most British-made tests are being sold abroad because of delays to certification and exacting standards to meet CTDA approval.
Omega Diagnostics, whose factory near Stirling was said to be ready to produce two million lateral flow tests a week, signed a contract with the NHS in March that would have been worth £374 million. It is sitting on government machinery worth millions but no order was ever placed.
The government let the contract expire in November and is now asking for £2.5 million to be repaid. Omega said it was “disappointing” that the government was asking for money back when it had spent it in good faith readying its manufacturing facilities and bringing on additional staff in preparation to supply the NHS.
Global Access Diagnostics, a social enterprise test manufacturer set up by the Bedford firm Mologic, was the other beneficiary of the March announcement. But Mologic’s lateral flow test did not pass Porton Down testing, despite being certified for use in Europe and having performed well in two independent studies. Continued in second post...
https://www.independent.co.uk/life-style/health-and-families/covid-lateral-flow-test-report-omicron-b1982704.html
Ludicrous when you compare results in the range 58% to 70% with Avacta results
Funtime - you are the Kent - you can't even get the correct form of you're. It should be the abbreviated form of you are not the possessive of you. But your're (see what I did there) such a pirck that you won't (a contracted form of will not) understand.
I read on the board about an email which seems to have dramatically to have detrimentally influenced the share price.
As far as I know I am all email lists
Avacta.LS@fticonsulting.com.
brighterIR
even Avacta themselves
But, I have received nothing.
Would some kind soul copy and paste the content on here for me.
Many thanks H
Whatever happened to HUA? Was it all a figment of someone's imagination.
I could have founded a company, build a building, done years of research and delivered to market.
BUT WE ARE STILL WAITING. IT IS GETTING BEYOND A JOKE, EVEN A VERY BAD ONE.