Sensyne Health (SENS) said its MagnifEyeÔ AI software has been granted ‘Authorisation of Special Use’ by the Medicines & Healthcare products Regulatory Agency ("MHRA").
The Oxford-based clinical artificial intelligence company said 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.
Sensyne explained to investors that the Innova lateral flow test was used because it is currently the only test to have received temporary MHRA derogation and that it will continue to be used with the Group’s MagnifEye software under the Authorisation of Special Use.
Sensyne built the MagnifEye smartphone app 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.
The Company launched the technology, which uses a cloud-based algorithm to automate the reading and analysis of lateral flow diagnostic tests, such as for COVID-19, in January 2021.
The app, which provides standardised results in under 2 seconds, can offer potential benefits to lateral flow test manufacturers and healthcare providers using it including, inter alia; improved accuracy, reduced risk of fraud and automated provision of validated test results.
Shares in Sensyne Health have increased by over 40% in value since the beginning of 2021. The stock was trading 2.14% higher this morning at 167p following the announcement.
Today, the Company said it is also pursuing a wider authorisation for the use of MagnifEye with other manufacturers' kits and for other medical indications and that it continues to work closely with its exclusive licence and technology partner, Excalibur Healthcare Services.
Sensyne signed an exclusive licence and development agreement with Excalibur back in February to apply MagnifEye with its proprietary lateral flow rapid diagnostic tests across a range of indications including its COVID-19 antigen test being marketed in the UK and across Europe.
Excalibur will pay Sensyne a royalty each time the MagnifEye is used to read a lateral flow test with a minimum guaranteed royalty sum of £4.8m payable over the first two years.
Beyond this initial agreement, Excalibur and Sensyne told investors at the time that both parties will seek to collaborate on the development of further projects that combine both ‘Excalibur's expertise in the development and marketing of high-quality diagnostic tests with Sensyne's expertise in the development and supply of software systems using clinical AI.’
"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,” said Lord (Paul) Drayson PhD FREng, CEO of Sensyne.
He added, “We believe our technology also demonstrates the value of AI in the analysis of medical images, a field that Sensyne has deep expertise in."
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