There has been much hoopla about the UK government’s decision to make two new rapid Covid-19 tests available to hospitals and care homes from next week. The move is intended to help meet the demand for widespread testing, and to help guard against a possible wintertime surge in infections.
It is almost impossible to tell how accurate these tests are, however. One of the manufacturers, Imperial College spinout DNAnudge, claims high accuracy figures, though the size and design of the trials conducted to provide these are a mystery. The other developer, Oxford Nanopore Technologies, has not made any accuracy claims at all. The government will be keen to avoid a repeat of the debacle in April, when UK officials paid £16m ($21m) for two million antibody tests that turned out not to work.
The UK government has paid rather more this time. The order with London-based DNAnudge is worth £161m; the company is best known for a technology that claims to enable people to make healthier food shopping choices based on the gene variants they carry. DNAnudge is to supply 5,000 of its Nudgebox machines to NHS hospitals, and 5.8 million Covid Nudge test kits to be run on them.
According to the UK’s Department of Health, the Nudgebox machines “analyse DNA in nose swabs” taken from suspected Covid-19 patients. This appears to be the DoH’s mistake rather than an accurate description of the technology: as a single-stranded RNA virus, Sars-CoV-2 does not contain DNA.
The polymerase chain reaction (PCR)-based tests themselves can return results in 90 minutes, and can also test for flu and respiratory syncytial virus, which have similar symptoms. The test is CE marked, and DNAnudge received exceptional use authorisation by the UK regulator the MHRA in early April.
According to the company, trials comparing Covid Nudge “against several NHS laboratory results” indicated 98% sensitivity and 100% specificity. According to Imperial College, in April the DoH obtained 10,000 DNAnudge Covid-19 testing cartridges for “large-scale clinical testing”. But no published data is yet available. What lab tests were used as the comparators? How many patients were actually tested, and where, and when? All this remains unknown.
Beyond describing its new LamPore Covid-19 test as “accurate” and “precise”, Oxford Nanopore has made no statements quantifying how good it is, and has not reported any figures for sensitivity and specificity. According to the company’s website, it has completed evaluations of analytical performance of LamPore, and the dataset “will be released soon”. The company did not reply to Evaluate Vantage's emails requesting further information.
450,000 of the tests are to be available from next week, with millions more coming later in the year. The tests, which use next-generation sequencing tech rather than PCR, run on Oxford Nanopore’s GridION or pocket-sized MinION machines, which can process up to 15,000 and 2,000 tests per day, respectively.
Unlike DNAnudge’s technology, the LamPore test does not seem to have yet obtained any UK regulatory go-ahead. Oxford Nanopore is currently in the process of CE marking LamPore for diagnostic use, and the MHRA website contains no record of exceptional use authorisation obtained by the company.
Neither the government nor Oxford Nanopore has disclosed how much money has changed hands in exchange for this technology. Still, shares in IP Group, which has a 16% stake in Oxford Nanopore, closed up 12% yesterday.
Side stepping a once-mooted IPO, the company raised money in January, at which point it was valued at around £1.7bn ($2.2bn). That funding round allowed Neil Woodford’s Equity Income fund, which is in the process of being liquidated, to sell down part of its holding in the company, according to the Times newspaper. IP Group also sold some of its shares as part of this transaction.
This valuation seems somewhat at odds with the group’s financial performance. According to its most recent accounts filing, Oxford Nanopore’s 2018 revenues came to £32.5m ($43.6m) and it made a loss of £53m.
|Oxford Nanopore's funding|
|26 May 2020||Undisclosed||59.2||Undisclosed|
|02 January 2020||Undisclosed||144.5||Undisclosed|
|18 October 2018||Undisclosed||66.0||Amgen Ventures|
|Mar 20, 2018||Series J||140.0||GIC, CCB International, Hostplus, existing investors|
|Dec 11, 2016||Series I||126.0||GT Healthcare, Woodford Investment Management|
|Jul 21, 2015||Series H||109.0||Undisclosed|
|Aug 12, 2014||Series G||59.0||Woodford Investment Management|
|Oct 9, 2013||Series F||64.0||Odey Asset Management|
|May 3, 2012||Series E||50.8||Undisclosed|
|Apr 26, 2011||Series D||41.0||Illumina, Invesco Perpetual, IP Group, Lansdowne Partners, Redmile Group|
|Feb 1, 2010||Series C||28.0||Invesco Perpetual, IP Group, Lansdowne Partners|
|Jan 11, 2009||Series B||18.0||Illumina|
|Mar 28, 2008||Series A||20.1||Undisclosed|