CovidNudge progressing to US clinical validation and assessment stage of global challenge, with opportunity for accelerated FDA approval
London, United Kingdom, December 22nd 2020 – DnaNudge has today been announced as a finalist for the XPRIZE Rapid Covid Testing competition for its CovidNudge 90-minute, lab-free RT-PCR testing innovation. As one of the top 20 best performing teams globally, DnaNudge will now have the opportunity to gain US clinical validation for the CovidNudge test from two world-class laboratories, helping to accelerate the FDA approval process.
The XPRIZE Rapid Covid Testing competition is a unique $6 million-dollar, six-month grand challenge that invites the world’s most innovative individuals and organisations to develop faster, cheaper, and easier to use COVID-19 testing methods – paving the way for more frequent testing at scale. The competition aims to increase COVID-19 testing capabilities at a factor of 100 times beyond the current global standard – the level of increase needed to more safely return to everyday activities. A grand prize of up to $1 million will be awarded to each of the top five winning teams that can demonstrate frequent, fast, cheap and scalable COVID-19 screening solutions to help meet the surging demand for tests and relieve the global supply chain. Finalist judging will take place from February 11th – 19th 2021, with the overall winners announced in February 2021.
“Fast, affordable, and accessible testing is crucial to containing the Covid-19 pandemic and safely reopening schools, businesses and other vital institutions around the world,” said Anousheh Ansari, CEO of XPRIZE. “XPRIZE Rapid Covid Testing is inspiring the best entrepreneurial and scientific teams to come together to work towards rapid, affordable Covid-19 testing at scale, and ultimately, getting the world up and running again.”
DnaNudge’s pioneering rapid CovidNudge RT-PCR test delivers highly accurate results without the need for a laboratory, pipettes or any manual sample pre-processing. A study recently published in peer-reviewed journal The Lancet Microbe showed that CovidNudge test’s average sensitivity – the ability to correctly identify those with COVID-19 – was 94.4% compared against standard UK NHS lab-based tests, while its specificity – correctly identifying those without the disease – was 100%, meaning no false positives were recorded.
Reverse Transcript Polymerase Chain Reaction (RT-PCR) testing usually requires a centralised laboratory and significant infrastructure, leading typically to a 1-2-day wait for results to be returned. DnaNudge’s portable point-of-care test has successfully miniaturised the gold-standard lab-based PCR test to be performed by a Wi-Fi-enabled, battery-powered device the size of a shoebox – the NudgeBox – that can be used anywhere to accurately detect the genetic material of the SARS-CoV-2 virus from a swab sample in just over an hour. Results are delivered to a Cloud and App and can be integrated into other software platforms.
Professor Chris Toumazou, CEO and co-founder of DnaNudge commented: “We are very excited to be moving into the US clinical validation phase of this incredibly important competition. What we have been able to deliver with our proven CovidNudge innovation is a gold-standard RT-PCR test that is fast, affordable, and easy to implement in any setting – making it a genuine game-changer that meets the global need for ubiquitous, highly reliable rapid testing. Because of the utility of our technology, numerous tests can be pooled at the same time on a single cartridge with minimal dilution, helping to further increase testing capacity, lower costs and optimise use of resources.”
CovidNudge’s novel Lab-in-Cartridge system works by placing a swab into a disposable “DnaCartridge” that can extract RNA from nasal and sputum samples. The cartridge is then inserted into the NudgeBox for analysis and reverse transcribing to DNA – delivering sample-to-result within 90 minutes. This multiplex technology – which is adapted from DnaNudge’s ground-breaking in-store consumer DNA testing service – can assess the presence of every published COVID-19 gene and also offers the capability to test for FluA, FluB and respiratory syncytial virus (RSV). The CovidNudge test ensures high accuracy and minimisation of ‘false negative’ results via a unique control that tests for human RNA, indicating inadequate swabbing and the potential need for a re-test.
Following a major UK government order for 5.8 million CovidNudge test kits in August 2020, the solution is in UK-wide roll-out across NHS urgent patient care and elective surgery settings, plus out-of-hospital locations. The CE-marked test has now also been made available in the UK as a rapid in-store and by-post service with the introduction of the DnaNudge COVID “Bubble Test” – offering lab-standard, highly-accurate COVID-19 group testing on one cartridge for “bubbles” of up to 10 people who do not have symptoms of coronavirus infection.
For more information about the CovidNudge test, please visit: https://www.dnanudge.com/en/COVID-Nudge
For further information about the XPRIZE Rapid Covid Testing Competition, please visit https://www.xprize.org/covidtesting and follow the hashtag #XPRIZE on social media.
About DnaNudge (http://www.dnanudge.com)
DnaNudge is the developer of the world’s first service to use consumers’ own DNA plus lifestyle factors to nudge people towards healthier choices while shopping. The DnaNudge service analyses and maps users’ genetic profile to key nutrition-related health traits such as obesity, diabetes, hypertension and cholesterol, enabling customers to be guided by their DNA towards healthier eating. The service has been developed by world-renowned biomedical engineer Regius Professor Chris Toumazou FRS and published geneticist Dr Maria Karvela.
This ground-breaking in-store DNA testing service created to address an epidemic – obesity and Type 2 diabetes – has now been successfully adapted for the fight against a pandemic, with the development of the rapid, lab-free CovidNudge RT-PCR test. CovidNudge can accurately detect COVID-19 and other viruses in just over an hour, without the need for a laboratory, and is now in UK NHS roll-out.
PRESS CONTACT for DnaNudge:
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