SENS.L Regulatory News (SENS)

Sensyne Health's MagnifEye AI software product gains MHRA 'Authorisation of Special Use' in connection with DHSC COVID-19 Self-Test Lateral Flow Device

Oxford, U.K. 07 May 2021: Sensyne Health plc (LSE: SENS) ("Sensyne" or the "Company"), the UK Clinical AI company, announces that its MagnifEyeÔ software application that uses AI to automate the accurate reading and analysis of lateral flow diagnostic tests, has been granted Authorisation of Special Use by the Medicines & Healthcare products Regulatory Agency ("MHRA").

The authorisation is specifically for the use of MagnifEye with the Innova COVID-19 lateral flow self-test kit, the platform originally used to test the MagnifEye technology as part of the NHS Digital pilot study. The Innova lateral flow test was used as it is currently the only test to have received temporary MHRA derogation and will continue to be used with MagnifEye under the Authorisation of Special Use.

The Company is also pursuing a wider authorisation for the use of MagnifEye with other manufacturers' kits and for other medical indications and continues to work closely with its exclusive licence and technology partner, Excalibur Healthcare Services Limited.

Lord (Paul) Drayson PhD FREng, CEO, said: "MagnifEye has demonstrated that it has the potential to play an important role in COVID-19 disease surveillance with increased lateral flow test reading accuracy and greater certainty over correct test interpretation. We believe our technology also demonstrates the value of AI in the analysis of medical images, a field that Sensyne has deep expertise in."

-ENDS-

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About Sensyne Health www.sensynehealth.com 

Sensyne Health plc Sensyne Health plc (LSE: SENS) is a clinical artificial intelligence company operating a unique business model - a for-profit plc making a positive social impact, sharing the financial returns it makes with health systems. The company applies clinical AI in the healthcare and life science industries. In healthcare, Sensyne delivers remote patient monitoring and real-time decision-making systems for healthcare organizations and their patients. In life sciences, Sensyne analyses large complex anonymized data sets to help life sciences companies accelerate the development of new medicines.

About MagnifEye

About MagnifEyeMagnifEye is Sensyne's proprietary cloud-based software application, available as both a smartphone app and a web application, that uses advanced, proprietary deep learning algorithms developed by the Company to automate the reading and analysis of medical images, including images of diagnostic test results, such as lateral flow tests.

The MagnifEye application for lateral flow tests was built in response to the demand generated by the COVID-19 pandemic for the accurate and standardised reading of lateral flow tests used for disease surveillance across large populations and the Big Data analysis of results in real time. Beyond COVID-19, MagnifEye has potential application in human and animal health including other infectious diseases, cancer, and fertility, as well as plant pathogen and environmental testing.