Innova4 Jun 2021 00:36
not sure if it's been posted already, anyway not all plain sailing for Innova it seems; c/o rocquet
https://www.independent.co.uk/independentpremium/covid-rapid-test-innova-latest-b1856023.html
Multi-billion contract on the line as UK regulator reviews rapid testing device for continued use
Special authorisation for use of the Innova lateral flow test, which currently expires on 22 June, is being reviewed by Medicines and Healthcare products Regulatory Agency, finds Samuel Lovett
A multi-billion contract the government signed with a US-based diagnostic firm could be in jeopardy if Britain’s medicines regulators does not renew its special authorisation of one of the most widely-used rapid home tests in the UK.
The Innova lateral flow test was first approved by the Medicines and Healthcare products Regulatory Agency (MHRA) back in December – but only under a time sensitive Emergency Use Authorisation (EUA) that expires on 22 June.
As part of contracts with the government worth around £3 billion, Innova has supplied more than one billion tests to the UK, which are being used as part of Downing Street’s twice-weekly mass testing programme – a crucial pillar of NHS Test and Trace.
However, the tests have been plagued by controversy. Fears have been raised that the devices are not sensitive enough and may incorrectly inform infected people that they do not have the virus, encouraging them to lower their guard and contribute to onward transmission.
The MHRA also reportedly expressed its concern with the Department of Health and Social Care (DHSC) that the mass testing programme unveiled by the government in April was “a stretch” of its authorisation for how the devices should be used.
It told DHSC in December that “we do not currently support” use of the device as “a ‘test to enable’ function” – in essence, one that would allow people greater freedoms if they returned a negative result.
However, according to the Guardian, the MHRA was worried that Downing Street did not make clear that the devices should only be used as a “red light” test to detect infectious people and order them to isolate.
Amid these blurred lines, and with limited data on how well the tests perform when taken by people who do not have Covid symptoms, the MHRA is now reviewing its emergency approval of the Innova device.
The test’s EUA was granted on 23 December and is due to expire this month. In a letter sent from the MHRA to the DHSC, and seen by The Independent, the medicines regulator said the device will be “reviewed” if there “continues to be a need for a further authorisation”.
“A decision [will be] taken on whether it remains in the interests of the protection of health for a further authorisation or an amendment to this authorisation to be made,” the letter read.
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