To ask the Secretary of State for Health and Social Care, with reference to the announcement from the US Food and Drug Administration on the poor efficacy of Innova covid-19 tests, whether he has plans for the (a) authorisation of alternative covid-19 rapid lateral flow tests, including those being produced in the UK and (b) extension of the exceptional use authorisation from the Medicines and Healthcare products Regulatory Authority following the extension of covid-19 restrictions.
21 June 2021
We are planning to diversify the supply of lateral flow devices (LFDs) and have begun to deploy other products in some settings, including the Orient Gene device. We will expand this over the coming months.
In December last year, the Medicines and Healthcare products Regulatory Agency (MHRA) provided the Department with an Exceptional Use Authorisation (EUA) which permits NHS Test and Trace to deploy the repurposed Innova COVID-19 as a self-test device throughout the United Kingdom as a test to detect infection in asymptomatic individuals. At this time an EUA was necessary due to a limited pool of suppliers offering a device which had passed the Government’s relevant validation tests and no suppliers had a CE mark for a COVID-19 self-test LFD. We will continue to work closely with the MHRA to ensure all available tests are safe and effective.