Sunday Times Article continued2 Jan 2022 05:57
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
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