RE: Times now reporting on Innova scandal too11 Jun 2021 18:57
Now in the Daily Telegraph:
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Blow for test and trace scheme as US watchdog queries rapid Covid tests
Innova has supplied the UK Government with more than 1bn rapid Covid tests under contracts worth more than £3bn
ByHannah Boland11 June 2021 • 5:40pm
Britain's test and trace scheme has been dealt a blow after US regulators cast doubt on the effectiveness of the rapid Covid-19 tests upon which it is based.
The US Food & Drug Association has issued a warning letter to manufacturer Innova saying its lateral flow tests violated a number of its rules, including failing to get approval, clearance or authorisation from the regulator.
It said the performance of the tests had not been "adequately established" and it was concerned about the tests giving false positives and negatives. It warned that estimates for how well the test picked up Covid-19 cases was "false or misleading" and "did not accurately reflect the clinical study data".
The FDA launched its investigation after it learnt that the tests were being distributed across the US despite not having regulatory approval. It conducted an inspection of a number of the company's manufacturing facilities between March and April.
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The regulator said it had "significant concerns" that the tests "could present a serious risk to public health" and called for those that had been distributed to be recalled or thrown away.
The US regulator's warning will prompt fresh questions about the UK programme. The Government has put the tests at the centre of its "Operation Moonshot" testing programme.
Innova has supplied the Government with more than one billion of its rapid Covid-19 tests under contracts worth more than £3bn.
The huge number of orders prompted Innova to announce last month that it would open a factory in South Wales to produce millions of tests a day.
Lateral flow tests are significantly cheaper than PCR tests and can be self-administered; however critics have argued they have too many drawbacks to be reliable, as they may miss a large number of positive cases.
Innova said it intended to seek authorisation from the FDA and added: "The scientific world acknowledges now no test is 100pc accurate, even the gold standard PCR test. False negative or positives can occur on both PCR and antigen tests. FDA has not done evaluation on Innova's test therefore they have to put the standard risk in the outline. Again, we have enough data to support the efficacy of the test."
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It added: "We understand FDA’s health risk concern for the US market as they have not evaluated or authorised the Innova test in the US. In simple terms, the regulator won’t confirm a product is safe to use until it has evaluated and authorised a product itself."