Boris Johnson has been accused of making “empty promises” to British bioscience firms after it emerged that new rapid Covid tests offered to NHS staff are manufactured by a Chinese firm.
Lateral flow tests made by Zhejiang Orient Gene Biotech, based near Shanghai, have been bought up at undisclosed cost by the Department of Health and Social Care.
HuffPost UK has learned that the DHSC is shifting away from its reliance on tests made by Innova Medical Group, a US-registered company that has won nearly more than £2bn in contracts for its own Chinese-made products.
The move had sparked hopes that home-grown firms, which claim to offer more reliable and cheaper tests, would finally get a share of Test and Trace’s huge £37bn budget.
But only one small British firm, SureScreen in Derby, has been contracted to provide rapid tests, and the much bigger ‘Orient Gene’ - as it is known - is being used to provide large numbers of diagnostics instead.
The first clue to the shift away from Innova came in new guidance for NHS managers and staff, which says they should expect a new test which differs in “the method of swabbing”.
The Innova test requires a swab from the back of the throat as well as the nose, a practice that is seen as uncomfortable for many. The OrientGene and SureScreen tests only need nasal swabs.
The new guidance, seen by HuffPost UK, states that all NHS staff can from July order their boxes of tests directly from the gov.uk website rather than have them supplied by their hospital trust.
Staff will be expected to use up their current Innova boxes, which contain 25 tests, before shifting to the new system.
The change also appears designed to ensure that tests are more accurately registered, following scathing criticism from the National Audit Office that nearly 600 million Innova tests were not being tracked.
Bridget Phillipson, Labour’s shadow chief secretary to the Treasury, said: “Handing this work to a Chinese company right after saying they wanted more lateral flow tests made in Britain is typical of this government’s empty promises to support British jobs and industries.
“Instead of using the powers they have to boost industry in Britain, they are instead happy to leave our economy weak and see British businesses losing out.
“Labour has a plan to buy, make and sell more in Britain to get our economy firing on all cylinders and for us to build up skills and businesses for the future as we recover from the pandemic.”
Speaking at the government’s Porton Down laboratory in November, Boris Johnson said: “We are seeing real progress on a UK-made lateral flow test. We’re not quite there yet but in the months ahead we’ll be making them in this country as well.”
Johnson went further earlier this year, when he declared: “We’ve created an indigenous industry not just to conduct lateral flow testing, but to make lateral flow tests.”
The DHSC told HuffPost UK it was “committed to ensuring that the UK has the testing supplies and equipment it needs”.
“As part of this, people may receive the DHSC branded Innova self LFD test, or an Orient Gene branded self LFD test. If the test will be conducted in an assisted setting, Innova, Orient Gene tests may be used.
“Collaboration between industry and government continues to be a priority and we are hugely grateful to all the manufacturers and suppliers who have come forward to offer their assistance in producing Lateral Flow Devices (LFDs).
“We are planning to diversify the supply of LFDs and have started to procure through fair and transparent competition via our LFD Dynamic Purchasing System.”
The DHSC insisted British innovation was at the forefront of its response to the pandemic and partnerships with British firms would help it “to build back better by tapping into the UK’s domestic talent, ingenuity and industry”.
Orient Gene tests have already been used by Test and Trace in its supplies to some schools and colleges, partly because their nasal swabbing is easier to use than back-of-the-throat swabs.
As part of the PM’s ‘moonshot’ plan to offer mass testing to the public, two free lateral flow tests per week have been offered in recent months, but that scheme is set to end in September.
If individuals are forced to pay for their own tests, a lucrative market could open up for those tests approved by regulators.
British firms have spent many months trying to persuade the Department of Health and Social Care (DHSC) to move away from the Chinese-made tests.
Earlier this year, DHSC agreed contracts with Omega Diagnostics, headquartered in Alva in Scotland and Global Access Diagnostics in Bedfordshire to provide manufacturing capacity for mass production of British alternatives.
Omega plans to use provide capacity for rapid tests tests using key pieces of manufacturing equipment loaned by the UK government, but it is still waiting for confirmation on which test it will be required to manufacture.
One UK company, Mologic, was so infuriated with the delays in approving its own test - which it says has passed WHO standards - that it threatened to sue the government.
One problem has been that British-made tests have failed to win full approval from the government lab at Porton Down, even though their own independent studies suggests they work well.
Frustrated biotech firms may end up selling their tests in Europe and the US rather than the UK, and some in Whitehall sympathise with their complaint that Porton Down processes are overly bureaucratic.
Neale Hanvey, MP for the Alba party, raised in prime minister’s question time on Wednesday the issue of Innova’s big government contracts and the failure to use rival tests made by Scottish-based firms such as Omega Diagnostics.
Hanvey pointed to the lack of progress since health minister James Bethell tweeted in March that British companies would be used to supply tests by May.
Hanvey asked: “Can the Prime Minister explain why his government is undermining the superior domestic diagnostics tests, while propping up discredited Chinese imports, to the tune of 3 billion pounds?”
Johnson replied: “I don’t think that’s an entirely fair characterisation of what the government is is doing. On the contrary, we have worked night and day to build up our domestic lateral flow capacity, and continue to do so.”
Innova, which is based in California and funded by a private capital group by a Chinese born businessman, uses tests produced by Chinese Biotime Biotechnology, in Xiamen city, Fujian province.
Concerns about cost and reliability have been raised repeatedly by critics, underscored when the US Food and Drug Administration (FDA) refused to approve its test after the firm made unfounded claims about its clinical data.
Americans were told last month to stop using Innova tests and throw them in the bin, but the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) did its own risk assessment and found no similar action was needed here.
Despite the criticism, the UK government leaned heavily on Innova during the recent second wave of Covid in early 2021.
The gov.uk website shows that the most recent contract was worth a massive £1.2bn for tests supplied from March to April. However, there are no published contracts for Orient Gene.
Following pressure from the government to get costs down, industry sources say that British manufacturers have managed to now offer their own tests at around £5 each, cheaper than Chinese rivals.
British company Avacta had its own AffiDX rapid test approved for professional use by the Medicines and Healthcare products Regulatory Agency (MHRA) in June. But there is slow progress in wider approval for public use.
Government insiders stress that Porton Down’s validation processes are the most thorough in the world and that while there is an effort to work with firms to try to get them to the right standard, patients and taxpayers deserve the best possible safeguards.
Ministers are understood to share the frustration of some of the firms but are adamant that the standards should be met. Out of courtesy to biotech companies, data on those products which fail the tests is not published. Data on those that do pass is published by the government.
Innova’s tests have come under fire for their reliability during the pandemic, with some academics pointing out that while they can pick up cases they are unsuitable for ‘test and release’ policies.
A new study published in the British Medical Journal on Wednesday, which looked in depth at Innova tests used in mass testing in Liverpool, found “the LFT missed 10% of people with a high viral load...and most of the cases with a viral load...who might have contributed to virus transmission.
“This suggests that care is needed when conveying negative LFT results so as not to give false reassurance,” it said.
However, a technical update published by DHSC on Wednesday defended the continued use of the Innova test, also known as the ‘Biotime Lateral Flow Device’, a reference to the Chinese factory where it is made.
“The Biotime LFD remains suitable for deployment as part of the asymptomatic testing programme to identify infectious individuals in the population and to reduce onward transmission risk at a local and national population level.
“There is no difference in performance in its ability to detect the Delta variant in comparison to the Alpha variant.”
However the update did hint at the greater use of British-made tests to cope with more variants of the virus.
“As further new variants emerge, and with increased diversity of LFD product manufacturers planned for deployment in the future, the combination of routine in vitro and clinical post-market surveillance will remain a critical tool for rapid surveillance of device performance in a changing landscape.”