Test and Trace: UK regulator extends approval for Innova Covid test, despite US recall
Britain’s medicines regulator has extended the emergency use approval for Innova’s rapid Covid tests, used for NHS Test & Trace, after the US said they “should be thrown in the bin”.
The MHRA approved the lateral flow tests for continued use, after carrying out its own checks over the last week.
Innova is the UK’s main supplier of rapid Covid tests for England’s test and trace system, and has been handed around £3bn in contracts by the government so far. The tests take around 30 minutes to produce a result.
But last week the US Food and Drug Administration (FDA) said “the tests should be thrown in the bin or returned.”
After an inspection of Innova’s California offices in spring, the regulator last week accused Innova of issuing 77,000 tests to the US market “without marketing approval, clearance, or authorisation from FDA,” and ordered a recall of all tests.
The FDA further scolded the California-based company for lifting data from another test supplier to use in its application for regulatory approval in the US.
Despite the FDA’s rebuke, Graeme Tunbridge, Director of Devices at the MHRA, said:
“We have now concluded our review of the risk assessment and are satisfied that no further action is necessary or advisable at this time.”
The emergency use authorisation period for Innova’s rapid tests in the UK was, however, shortened from sixth months to two by the regulator.
In response to the FDA’s allegations, the company said: “The Innova rapid antigen test has been widely used, studied, tested, scrutinised and analysed with data supporting the efficacy of the test from the largest mass testing program out of the UK.”
“Innova understands the FDA’s health risk concern for the US market as they have not evaluated or authorised the Innova test in the US,” it added.
Boris Johnson has stressed the important role that regular asymptomatic testing will play in reopening the economy, but some scientists have questioned the Innova test’s accuracy and value.
A study released by the government’s Scientific Advisory Group for Emergencies (Sage) showed the test was capable of picking up just under half of active infections, while separate research by the University of Liverpool found it only identified around 40 per cent of asymptomatic cases.
Scientists have warned that these false negatives could do more harm than good in the spread of coronavirus amongst the UK population.