Excalibur Healthcare Services has revealed that its COVID-19 self-testing system featuring a unique app powered by artificial intelligence has been given Europe-wide regulatory certification in a world-first decision that can revolutionise personal and home-based diagnostics.
The Test To Go app was developed in partnership with Oxford Science Park based clinical AI company, Sensyne Health plc using its MagnifEye technology which underwent extensive testing trials with the Department of Health & Social Care (DHSC).
The Excalibur Test To Go app used in conjunction with the Excalibur CE-marked lateral flow test is the first testing system of its kind to receive full certification and could have a game-changing impact on self-testing, said the company.
The system enables people to take a lateral flow test, record the result through the app and receive fast certification of their status from Excalibur’s laboratories in Cambridge. Results are automatically sent to Public Health England averting the need for users to complete additional form filling.
Further trials of the app undertaken by Excalibur and involving more than 15,000 human test samples demonstrated that the deep-learning algorithm used in the app meant that the accuracy of test readings was up to three times better than the human eye.
The CE certification of the system for Europe and the UK means that the public will be able to test themselves for COVID-19 at home, at work, or for travel using the most accurate technology available. Excalibur is now preparing to file for full FDA registration of the system.
Professor Sir Chris Evans*, chairman and chief executive of Excalibur Healthcare Services, who lives in Gloucestershire, said: “We are delighted that this easy-to-use, highly accurate, all-in-one system has now received regulatory certification. It will revolutionise COVID self-testing and diagnostics for people in the UK, Europe and worldwide.
“Until now, we have been able to supply tests on their own but the certification for the complete system including the app has taken the diagnostic capability to a new level. In our own Cambridge laboratories we are already looking at applying this unique system to diagnostic tests for other important human conditions.”
The Test To Go system is fully automated and paperless. People who have taken tests receive digital confirmation of their COVID-19 status and an email certificate within minutes of recording their tests results.
Lord (Paul) Drayson PhD, CEO of Sensyne Health, said: “This is a major scientific achievement and, we believe, a world first in developing a regulated software application using state of the art AI to enhance the accuracy of lateral flow testing and reporting. This important milestone provides access to a key commercial market and potentially will have a major positive impact on improving the reporting of COVID lateral flow tests and supporting societies’ recovery from the pandemic.
“This news underlines the significant potential of our MagnifEye technology which is helping to automate and improve the accuracy of reading images in many diagnostic testing and medical imaging applications.”
*Prof. Sir Chris Evans OBE is a highly successful and internationally renowned scientific entrepreneur. He has launched, financed and built more than 40 life sciences companies from their inception and now valued in excess of $7 billion. Twenty of these companies were listed on six separate stock exchanges around the world during a career spanning 35 years. Sir Chris has returned $billions in cash to investors. Notable companies include Ellipses Pharma, Excalibur Healthcare Services, Chiroscience, Celsis, BioVex, ReNeuron, Vectura, Piramed, Arakis, Arix, Rutherford clinics and Merlin Biosciences Ltd.
Appointed OBE in 1995 for services to medical bioscience, he was then one of the youngest scientists to be knighted in 2001 for services to bioscience and enterprise. He has advised four UK Prime Ministers on pharmaceutical, life sciences and healthcare policy over the year as well as overseas governments including Algeria, Libya, Malta, Qatar and the United Arab Emirates.
He holds numerous professorships, fellowships and honorary doctorates in science at some 16 British universities and he has been the author of more than 100 scientific publications and patents.
Sir Chris has raised more than $3billion of investment for research projects, developing over 50 innovative medical products. Sir Chris has always had a strong focus on cancer research and clinical development of new cancer medicines and has raised more than $2billion for cancer research projects over the years.
He has a keen interest in rugby, wine, beer, health and fitness and music.