NCYT7 Aug 2020 16:51
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 been approved by the regulator, the Medicines and Healthcare Products Regulatory Authority (MHRA). Before Covid-19, Oxford Nanopore had been involved only in research – not tests for patients.
About 80 other molecular tests had a CE-mark from the MHRA as early as April. DnaNudge was granted an emergency exemption by MHRA and can be used without the CE mark.
Oxford Nanopore and DnaNudge were first name-checked by the health secretary, Matt Han****, 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.
Han**** 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, Han****’s department signed an initial contract with DnaNudge for £3.3m, followed by one for £161m on 1 July.
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.
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“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 Han****.
“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.”
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