Today
Fri 17 September 2021

An exclusive investigation by The Citizens and the Byline Intelligence Team reveals just how dependent the UK’s testing capability is on foreign imports

The UK is increasingly dependent on importing rapid antigen tests to detect COVID-19 – despite British-based manufacturers being able to produce and sell such tests, an investigation by The Citizens for the Byline Intelligence Team can reveal.

Of the £4.5 billion spent so far by the Government on purchasing Coronavirus tests, almost £4 billion has gone to Chinese or US-based companies. This compares to 11% of the total spend being awarded to two UK-based companies: SureScreen Diagnostics and Una Health Ltd.

Overall, just six of the 34 companies that had their tests accredited by the Porton Down Government testing facility are UK-based. Of these, only SureScreen has won significant contracts to supply COVID-19 tests, with a smaller amount – £1.7 million – of tests by Fortress Diagnostics being purchased through the company Una Health Ltd.

The biggest supplier of rapid antigen tests in the UK is the US-based Innova Medical Group, which has received £3.3 billion worth of Government contracts – most recently one on 13 June worth £144 million. It dominates the UK market, despite questions having been raised over the efficacy of its tests. A recent Liverpool community testing pilot study found that Innova’s rapid antigen tests only detected 40% of Coronavirus cases, while the US Food and Drugs Administration has advised throwing the tests in the “trash”.

A report by the LA Times indicated that Innova snapped up Coronavirus tests from an obscure Chinese manufacturer and so was able to supply them in large quantities to the UK early on in the pandemic. But why the Government was still signing contracts with Innova in June 2021 when other manufacturers were available to produce tests is unknown.

Alongside Innova, the Government imports Chinese-made Orient Gene tests from the US-based Tanner Pharma, as well as the Chinese ACON Biotech Flowflex test provided via UK-based Medco Solutions Ltd.

Despite the dominance of such imports, British companies continue to struggle to get their rapid antigen tests on the market. Some have privately expressed concern that the UK is relying too heavily on Chinese-manufactured imports, rather than investing in domestic manufacturing capacity. This dependence on imports raises the risk of shortages should there be supply chain issues in the future. It also undermines the Government’s commitments for greater economic autonomy post-Brexit. 

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Although the Government claims that SureScreen Diagnostics’s tests are “British-made”, a Surescreen representative told Byline Times that “unfortunately you cannot buy some of the key materials required to make [rapid antigen tests] in the UK, so we do have to source material from the EU, US and Far East depending on what the material is”. SureScreen confirmed that its research and development team was based in the UK.

Last April, the Government set up a business consortium to encourage the manufacture of Coronavirus tests in the UK. Abingdon Health, a UK-based company, was subsequently awarded a contract to provide antibody tests (rather than antigen tests). However, a judicial review on the awarding of this contract by the Good Law Project has meant the Department of Health and Social Care refusing to release the £6.7 million it owes to Abingdon.

A recent market report on Abingdon Health noted that the company faces losses of £3.3 million for the year and was being forced to lay-off at least 60 staff, as Abingdon’s shares dropped 20%. The Citizens has learned that, in June, Health Minister Lord James Bethell contacted the members of the testing consortium, telling them that the Government would “draw the RATS (rapid antigen tests) consortium efforts to a close”.


Frustrated Accreditation

A number of other UK companies manufacturing rapid antigen tests have spoken of frustrations around the process for accrediting tests, which they say is too long. They are also concerned about poor communication from the Government.

One manufacturer, Mologic, which had tests rejected by Porton Down, received a £1 million grant from the Government. Its medical director, Dr Joe Fitchett, said that its tests are “completely designed, manufactured and assembled in the UK” and that “some components of the test kit (e.g. swab) are imported”.

The Porton Down scientific accreditation laboratory recorded a 60% failure rate in Mologic’s tests. Other labs in the UK and in Germany gathered very different results: they found that the tests only had a 1-2% failure rate.

The Mologic test was accredited for professional use with the CE Mark last December, meaning that it can be used by trained medics. The company’s tests “demonstrated high performance in independent clinical studies, including in a recent evaluation for the World Health Organisation by the Bill and Melinda Gates Foundation and Geneva-based Foundation for Innovative New Diagnostics”.

Despite such assurances, the Porton Down results mean that Mologic’s tests cannot be used by the UK public. None of the results of the Porton Down laboratory tests have been made public. The results are sent directly to companies and some are asked to sign non-disclosure agreements.

Mologic’s chief executive, Mark Davis, told The Telegraph: “We are quietly confident that this is one of the best rapid lateral flow diagnostics in the world, it is made in Britain and the UK doesn’t want it. All we have requested is for Porton Down to evaluate the test with an independent party observing”.

Despite requests, the Department of Health and Social Care has so far refused to independently verify Porton Down’s results that led to Mologic’s tests being rejected. Mologic is now considering legal action. It accuses Porton Down of lacking transparency, having a “potentially misleading laboratory-based evaluation for assessing rapid tests”, and of missing an opportunity to support UK-based research and development in diagnostics for epidemic threats.


Unused British Manufacturing Capacity

UK-based Omega Diagnostics was awarded a £374 million contract to manufacture rapid antigen tests in the UK and Omega’s machines are configured to start producing Mologic’s tests. But it does not have permission to do so.

Similarly, Global Access Diagnostics (GAD) has been awarded a contract worth between £50 million and £1.15 billion to manufacture tests. As the sister company of Mologic, it is keen to produce its own tests. But, five months after being awarded the work, neither Omega or GAD have been told by the Government what type of Coronavirus tests they will be allowed to manufacture. Neither company has received a purchase order or any money in payment for their tests, despite being awarded contracts to manufacture them.

However, Omega has been producing the Mologic test under its own Visitect brand for export to other countries, while other UK companies such as Excalibur also export rapid antigen tests to other countries.

Despite the UK ‘Test and Trace’ strategy being reliant on imported rapid antigen tests from companies such as Innova, this investigation has also found that British-made lateral flow tests are being exported abroad.

This is in spite of the then Health and Social Care Secretary Matthew Hancock describing the two awards as putting “British innovation… at the forefront of our response to this pandemic”.

“This partnership with two Great British firms will help us to build back better by tapping into the UK’s domestic talent, ingenuity and industry,” he added.

Omega released a statement seeking to reassure shareholders after the company lost 10% of its value due to the manufacturing delays. It explained that “while confirmation from the Department of Health and Social Care of which test to produce has taken longer than we had expected, we are confident that we have the capacity to produce significant volumes of tests once we receive the requisite confirmation”.

A spokesperson for the Department of Health and Social Care said: “The UK is leading the way in medical diagnostics and testing to stop the spread of COVID-19, and any lateral flow devices operationalised by the programme must pass a rigorous validation process to make sure they are accurate, reliable and safe”.

Further requests asking why Porton Down was refusing to re-run tests on Mologic’s rapid antigen tests and why it was refusing to respond to Mologic’s requests for oversight of the accreditation process were ignored.

This article was produced by the Byline Intelligence Team – a collaborative investigative project formed by Byline Times with The Citizens. If you would like to find out more about the Intelligence Team and how to fund its work, click on the button below.

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