Clinical AI company Sensyne Health has been granted Authorisation of Special Use by the Medicines & Healthcare products Regulatory Agency (MHRA) for its MagnifEye software application that uses AI to automate the accurate reading and analysis of lateral flow diagnostic tests.
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, 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.”
