AI-powered 'Test-To-Go' system receives CE mark

Clinical AI company Sensyne Health’s licence and development partner, Excalibur Healthcare Services, has received European regulatory certification, which includes the UK, for its ‘Test-To-Go’ COVID-19 antigen testing system powered by Sensyne’s MagnifEye.

The Test-To-Go system powered by MagnifEye includes the Excalibur lateral flow test (“LFT”) CE-marked for self-testing, as well as the CE marked 'Test to Go app', which includes Sensyne’s AI-powered image analysis technology MagnifEye which provides AI-enabled automated accurate and consistent reading of Excalibur LFT results.

Excalibur together with Sensyne will work to drive adoption and use throughout the European Economic Area and the United Kingdom in the use of COVID-19 lateral flow testing across commercial and government settings.

MagnifEye is already being used as part of the Department of Health & Social Care’s COVID-19 testing programme in the NHS and has read and recorded more than one million lateral flow antigen tests to date. Independent research has shown that the use of MagnifEye significantly increases the reading accuracy of lateral flow testing.

MagnifEye is a deep learning algorithm capable of objectively reading COVID-19 lateral flow tests with extremely high accuracy in less than two seconds classifying tests as ‘positive’, ‘negative’, ‘void’ (where a test control line cannot be seen) or ‘invalid’ (where the test fails to meet quality control criteria). MagnifEye uses a smartphone’s camera capabilities, reading and interpreting faint lines on lateral flow images to increase the ability to identify positive tests, reduce fraudulent tests and support infection control efforts.  The technology is also anticipated to identify COVID-19 cases with low viral load which may have been missed by a human reader.

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.”

Professor Sir Chris Evans, chairman and chief executive of Excalibur Healthcare Services, added: “This is a great result for British technology and partnership between two UK-based companies. I am delighted we secured this regulatory certification on behalf of Excalibur and Sensyne and I am particularly excited about the applications for non-COVID diagnostics we are developing in our state-of-the-art laboratories in Cambridge.”