Innova tests’ performance not proven and they should be returned to manufacturer or thrown in bin, says FDA
The US Food and Drug Agency (FDA) has raised significant concerns about the rapid Covid test on which the UK government has based its multibillion-pound mass testing programme.
In a scathing review, the US health agency suggested the performance of the test had not been established, presenting a risk to health, and that the tests should be thrown in the bin or returned to the California-based manufacturer Innova.
…In its report, the agency accused the company of “false or misleading” estimates of the clinical performance of certain configurations of the test, saying the estimates did not accurately reflect the performance of the diagnostic devices during clinical studies.
This is the first instalment of my three-part investigative report on the Chinese-made Innova lateral flow test. Vast sums of UK taxpayers’ money have been paid to a California start-up for tests that have failed to stand up to scrutiny.
…Innova Medical Group, the company benefiting from the UK Government’s huge testing contract, is owned by the private equity group Pasaca Capital which was founded by a Chinese investment banker, the enigmatic Dr Charles Huang, in 2017. It has been revealed to be the single largest recipient of the Department of Health’s Covid contracts after signing a £496million deal to supply LFTs last year. An earlier contract with Innova cost the taxpayer £107million.
The UK’s healthcare regulator has expressed concern to the government that its multibillion-pound mass testing programme is “a stretch” of the authorised use of rapid tests, the Guardian has learned.
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the lateral flow devices to be used to find coronavirus cases but not to act as a “green light” for people who test negative to enjoy greater freedoms.
The regulator is concerned that people who test negative will be given false reassurance by their result and will let down their guard if they believe they are Covid-free.
There is very little data to show how well the Innova lateral flow devices detect the virus when used as a self-test by someone who has no symptoms. They are being used by millions of people a week in England under the government’s universal testing programme.
Spending the equivalent of 77% of the NHS annual revenue budget on an unevaluated underdesigned national programme leading to a regressive, insufficiently supported intervention—in many cases for the wrong people—cannot be defended.