The government has placed a £161 million order for 5.8 million high-speed DnaNudge COVID-19 test kits to be used in NHS hospitals from September.

This major order will see DnaNudge’s lab-free, rapid and reliable PCR test, which delivers results in under 90 minutes and can work in about an hour, rolled out nationally in urgent patient care and elective surgery settings, with further deployments in out-of-hospital settings. 

I am hugely grateful to DnaNudge and their incredible work to innovate coronavirus testing, which will mean we can test millions more people in the coming months. Matt Hancock MP Health Secretary

DnaNudge, an Imperial startup headquartered in White City, recently obtained a CE mark for its COVID Nudge test, enabling its additional use in non-clinical locations, including care homes and other public emergency services.  

The COVID Nudge test adapts DnaNudge’s consumer service, which was launched last year to analyse and map users’ genetic profile to key nutrition-related health traits such as obesity, diabetes, hypertension and cholesterol, enabling customers to be “nudged” by their DNA towards healthier eating.

Working with DHSC, and with the authorisation of the MHRA, DnaNudge validated its adapted technology in April and began an initial deployment of the COVID Nudge test in eight London hospitals – including cancer wards, A&E and maternity departments at St Mary's Hospital in Paddington, Charing Cross Hospital, West Middlesex University Hospital, Chelsea and Westminster Hospital, Royal Hospital Chelsea, Queen Charlotte’s and Chelsea Maternity Hospital, the Renal Transplant Centre at Hammersmith Hospital and the Tower Hamlets Centre for Mental Health at Mile End Hospital. 

The technology builds on a series of innovations developed by Professor Christofer Toumazou and his team at Imperial’s Department of Electrical Engineering and the Institute of Biomedical Engineering, originally with other applications in mind. These advances include novel integration between biochemistry microfluidics, electronic circuits and miniaturisation based on smartphone technology. Use cases of the COVID Nudge test include A&E, elective surgery, paediatrics and outpatients, as well as maternity care, where expectant mothers who exhibit COVID-19 symptoms during labour can now be tested very quickly to ensure that the best and safest course of action is taken, and that mother and baby are not separated unnecessarily.

Rapid, accurate and portable

The COVID Nudge test is a rapid, accurate, portable, out-of-laboratory, sample-to-answer RT-PCR test that delivers results on the spot, at the point of need and in just over an hour. This transformative, single-chip multiplex test not only enables a comparison of a sample against both the WHO and CDC assays but could also test for FluA, FluB and RSV. In addition, the chip includes a control assay for human RNA, which eliminates “false negative” results by testing for inadequate swabbing.

Early trials comparing COVID Nudge against several NHS laboratory led to MHRA derogation. Further tests indicate sensitivity of 94.4% (between 86-98%, with a 95% confidence interval) and a specificity 100% (99-100%, with a 95% confidence interval). The team have submitted their findings, which are currently undergoing peer-review, for publication. 

We can test not only for COVID-19 but also FluA, FluB and RSV on the same single COVID-19 Nudge cartridge Professor Chris Toumazou Regius Professor of Engineering

Dr Gary Davies, Hospital Medical Director of Chelsea and Westminster Healthcare NHS Foundation Trust, which is using the test within Chelsea and Westminster’s A&E, elective surgery and paediatrics departments, said: “ The opportunity to have this highly accurate test – without the need for a laboratory – is helping us to provide the highest quality care for our patients and support for our staff, and offers the best chance of tackling the biggest challenge that the NHS has ever faced, particularly now as we look ahead to the winter flu season.”  

With results delivered in a little over an hour, the DnaNudge test offers a major improvement on current lab-based PCR testing, which can involve a 1-2 day delay before returning results. 

Professor Graham Cooke, NIHR Research Professor of Infectious Diseases at Imperial, who led the clinical development, said: "Early work involving thousands of people in clinical settings show that this PCR test is fast, reliable and accurate. We hope the DnaNudge COVID test will serve as a powerful tool for those frontline NHS workers who need it most."

'Research, discovery and creativity'

Professor Alice Gast, President of Imperial College London, said: “Chris Toumazou’s work to develop, adapt and roll-out such effective tests exemplifies how academic innovations are helping the NHS frontline and the patients they serve. His team’s research, discovery and creativity, and the government’s wise investment, will support those patients and health workers who most need access to rapid COVID-19 tests.”

Professor Chris Toumazou FRS, CEO and co-founder of DnaNudge and founder of the Institute of Biomedical Engineering at Imperial College London, said: “The DnaNudge team worked with incredible speed and skill during the peak of the pandemic to deliver this highly accurate, rapid COVID-19 test, which requires absolutely no laboratory or pipettes and can be deployed anywhere with a direct sample-to-result in around just over an hour. We have been able to successfully adapt our in-store consumer DNA testing technology – which identifies genetic risks for chronic conditions related to obesity and Type 2 Diabetes – and validate it for detecting COVID-19 with gold-standard accuracy.

“We are extremely proud to be playing such a pivotal role in supporting the national effort on testing, as this major contract award signifies. With the ability to test not only for COVID-19 but also FluA, FluB and RSV on the same single COVID-19 Nudge cartridge, our multiplex test offers a vital solution to protect the NHS as we head into the flu season.”

Health Secretary Matt Hancock said: “By quickly detecting whether the virus is present in an individual, this new test is an important step forward in point of care testing which means that positive cases can be identified and contained quickly and safely.

“I am hugely grateful to DNANudge and their incredible work to innovate coronavirus testing, which will mean we can test millions more people in the coming months.”

Update 4 August: Further detail added on sensitivity and specificity, and submission for peer-review and publication. Previously mentioned only MHRA derogation findings of 98% sensitivity and 100% specificity.