Thank you for contacting me about Innova and lateral flow devices.
As you are aware, Innova are the supplier of NHS Test and Trace lateral flow devices.
In December last year, the Medicines and Healthcare products Regulatory Agency (MHRA) provided the DHSC with an Exceptional Use Authorisation (EUA) which permits NHS Test and Trace to deploy the repurposed Innova COVID-19 as a self-test device as a test to detect infection in asymptomatic individuals.
In light of the US Food and Drug Administration’s warning about LFDs, it is right that a full risk assessment was undertaken by DHSC, as legal manufacturer of the devices in the UK, and that the MHRA undertook a thorough review to ensure that they were satisfied with the assessment and any action proposed. Following what the MHRA has described as a satisfactory outcome of the review, Exceptional Use Authorisation was extended to 28th August 2021.
I have been assured by my colleagues in the Department for Health and Social Care that the tests have been through the rigorous Porton Down assessment process and robust quality assurance processes are in place. While I note your comments about these tests, I am satisfied that they have met the necessary standard and share the Government’s confidence in these tests.
I note your comments regarding the exemption from new laws to validate the accuracy of tests of tests which are currently supplied to the NHS under DHSC procurement. These tests are exempted as they have been recognised as validated under a prior, equivalent assessment. I support this exemption and have full confidence in the process that they have gone through.
I understand that the Government is planning to diversify the supply of lateral flow devices (LFDs) and has begun to deploy other products in some settings, including the Orient Gene device. This will be expanded over the coming months and I will be following developments closely.
These tests have helped to save thousands of lives by identifying asymptomatic cases of COVID-19. Around 1 in 3 people who have coronavirus never show any symptoms but may still be infectious. This means they could be spreading the virus without realising it and so asymptomatic testing is a vital tool as we work towards ending this pandemic.
Thank you again for taking the time to contact me.
Gillian Gillian Keegan MP Member of Parliament for Chichester
This is the lateral flow test to open the economy again. Great news for all businesses not least airlines. We will finally have a sovereign test that is sensitive enough to allow travel to resume. By far the best in class. 20 mins for a result and anterior nasal instead of the brain ticklers we have at present.