RE: Mologic to sue government article - Telegraph14 Jun 2021 19:54
pt3
Mologic is submitting for approval a lateral flow test aimed at the American home-testing market to the US drugs regulator, the FDA. It was given an $11m grant by US authorities to develop it and, if approved, it could go on sale there in a matter of weeks.
The UK has relied heavily on US-based Innova to supply it with lateral flow tests. Innova is owned by private equity firm Pasaca Capital, which was founded by Charles Huang.
Innova has supplied the Government with more than a billion rapid tests under contracts worth more than £3bn.
Last week the FDA issued a warning saying the Innova test should not be used and should be "put in the trash" after issuing a "class 1 recall" - the most serious - amid concerns over the test’s accuracy.
The FDA has accused Innova of, among other things, submitting falsified data and distributing the test in the US without FDA approval.
A Department of Health and Social Care spokesman said: "Collaboration between industry and government continues to play a central role in our response to this pandemic and we are hugely grateful to all manufacturers and suppliers who have come forward to offer their assistance in producing lateral flow tests during this unprecedented time.
"The UK is leading the way in medical diagnostics and testing to stop the spread of Covid and any lateral flow devices must pass a rigorous validation process to make sure they are accurate, reliable and safe."