Revealed: UK's rapid Covid test not yet approved by regulators

One of two 90-minute rapid coronavirus tests bought by the UK government and announced on Monday has yet to be approved by regulators, while no data on the accuracy of either has been published, the Guardian has learned.

The test, from Oxford Nanopore, a young biotech company spun off from Oxford University, has not yet gained a CE mark. Before Covid-19, Oxford Nanopore had been involved only in research, not tests for patients.

About 80 other molecular tests had a CE mark as early as April. DnaNudge was granted an emergency exemption by the Medicines and Healthcare Products Regulatory Agency to be used without the CE mark.

Oxford Nanopore and DnaNudge were first name-checked by the health secretary, Matt Hancock, in a Downing Street press conference on 1 May, the day he announced his target for reaching 100,000 tests per day in England had been met.

Hancock profusely thanked British efforts to upscale and upgrade testing. He mentioned both companies again from the same podium on 21 May.

Unlike Oxford Nanopore, DnaNudge - the brainchild of an eminent professor at Imperial College London - is ordinarily consumer-facing, with a flagship store in Covent Garden, London. DnaNudge sells wristbands in a variety of colours containing your DNA in a capsule, analysed from a one-off cheek swab. Linked to a smartphone app, the wristband will advise on whether to buy food products, flashing red or green when you scan the barcode.

As early as 22 April, Hancock’s department signed an initial contract with DnaNudge for £3.3m, followed by one for £161m on 1 July.

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It was not until 3 August that the government announced it was buying “millions of ground-breaking rapid coronavirus tests” from the two companies, which would be “rolled out to hospitals, care homes and labs across the UK to increase testing capacity ahead of winter”. They would also detect flu.

“We’re using the most innovative technologies available to tackle coronavirus. Millions of new rapid coronavirus tests will provide on the spot results in under 90 minutes, helping us to break chains of transmission quickly,” said Hancock.

“I am hugely grateful for the excellent work done by DnaNudge and Oxford Nanopore to push forward these life-saving innovations in coronavirus testing.”

Jon Deeks, professor of biostatistics at Birmingham University who is conducting an evaluation of such tests, said he had not come across either of them when the government announcement was made.

“It looks like a decision that was raced through. They are making decisions before anybody knows the results as to how well they work,” said Deeks. “They are not making clear comparisons with the alternatives, which means that British people might not get the best tests.”

The Royal Statistical Society has set up a working party to produce guidance on what data is needed before a test for an infectious disease is approved.

In a letter to the Guardian, citing the lack of data over the new rapid tests, it said: “We recognise that the stakes are high and that decisions need to be made quickly. However, this makes it even more important that data is used in a responsible and effective manner. Transparency around the data that is being used to inform decisions is central to this.”

Dr Stuart Hogarth, lecturer in Sociology of Science and Technology at Cambridge University, said: “There is absolutely no transparency about how these contracts were awarded. If the UK government had wanted to support UK firms, there are a number of other companies that might have been interested in bidding … What was the validation process?” .

Robyn Meurant, an executive director of NSF International, an international not-for-profit body that helps companies meet regulatory standards, said neither test had conventional approval. “One of them [Oxford Nanopore] says on its website they haven’t reached a regulatory status at this point and yet they’ve already been chosen,” she said.

“The other one [DnaNudge] has had an emergency exemption. It hasn’t gone through the normal pathways. It doesn’t mean it will be bad, but it is a red flag that these are early products.”

Neither company has a track record in such tests. “We have these two fairly young players. We’ve never seen them produce at scale before. Manufacturing is always most risky during that scale-up period. It is all right to be able to produce a few hundred for demonstration but then to suddenly have to produce hundreds of thousands takes a different expertise,” she added.

There are still ways the government can “de-risk” the decision, particularly by holding off rollout until the regulatory requirements are fulfilled, she said.

Both companies said evaluations had been carried out. Oxford Nanopore had collaborated with labs in London, Sheffield, Birmingham and Oxford to produce data that would soon be published. DnaNudge says it has submitted its results for publication. Trials showed sensitivity of 94.4% and the test was able to differentiate Covid from other viruses 100% of the time. Eight London hospitals are using it.

The Department of Health and Social care said it was standard practice to start using tests while they were being accredited, as long as they had some formal evaluation. It was also looking at other companies.

“We are continually looking for new, innovative approaches as part of our national testing programme,” said a spokesperson.