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UK drug regulator to investigate Covid tests after FDA concerns

           

US Food and Drug Administration says performance of Innova lateral flow tests not “adequately established”

The UK’s medicines regulator has agreed to undertake a “full risk assessment” after the US Food and Drug Administration raised “significant concerns” over rapid Covid-19 tests that are being widely deployed in the UK.

In a review dated 10 June, the US health agency said the performance of Innova’s lateral flow Covid-19 tests had not been “adequately established, presenting a risk to health”, noting the “potential risk of false results”.

It recommended that test users “destroy the tests by placing them in the trash” or else return them to Innova.

The findings have raised serious concerns in the UK, where the tests have been offered free to millions in England as part of the mass-testing scheme, Operation Moonshot. In response, the company and the UK government have both strongly defended the tests.

‘Urgent risk assessment’

“Given the issues raised, it is important that risk assessments are urgently undertaken in the UK…to assess whether similar risks occur with the supply and distribution of this test in the UK,” said Jon Deeks, a professor of biostatistics and head of the Biostatistics, Evidence Synthesis and Test Evaluation Research Group at the University of Birmingham.

He added that, while several of the issues raised by the FDA relate only to the distribution of the test in the US, some of the concerns “may have a broader impact”.

Deeks also criticised what he described as the “lack of transparency in the evidence to support the government’s policies” for the use of the test, which he said “negatively impacts on uptake”.

“Given the more serious concerns identified by the FDA, it is essential that full explanations and data are provided to explain decisions made about its continued use, if that is the decision made,” he said.

Sheila Bird, former programme leader of the Medical Research Council’s Biostatistics Unit at the University of Cambridge, agreed that the MHRA needs “urgently to clarify the extent of read-across from across the pond to the 7-kit lateral flow test-packs which DHSC has made available to UK citizens for twice-weekly asymptomatic screening”.

Graeme Tunbridge, MHRA’s director of devices, told Research Professional News that the regulator was aware of the FDA’s review.

“The MHRA are reviewing all available information and are working closely with NHS Test and Trace to ensure that a full risk assessment is undertaken, as is our normal process, to understand any implications for products being used in the UK,” he said.

“Patient safety is our main priority and we will issue safety information as and when necessary.”

A Department of Health and Social Care spokesperson maintained that the UK government is confident about the tests’ use.

“The Innova test has already gone through the UK’s rigorous Porton Down assessment process, and we have a robust quality assurance process in place,” they told Research Professional News.

“We have confidence in lateral flow tests, which help us identify people without symptoms but who could pass the virus to others—helping break the chains of transmission.”

The publication of the review comes after the Royal Statistical Society’s Working Group on Diagnostic Tests called on the MHRA to review and revise the national licensing process for diagnostic tests.

The group said there should be a “common statistical benchmark” for evaluating the performance of diagnostic tests.

It also said legislation should require tests to be evaluated in the settings where they would be used, and for that evidence to be independently scrutinised and made publicly available.

A spokesperson for Innova said: “There is absolutely no link between the FDA’s action regarding the process for authorisation in the US and the situation in the UK. We have robust data proving the quality of the product in many other jurisdictions with the largest data set from the UK.”

“The Innova rapid antigen test has been widely used, studied, tested, scrutinised and analysed with data from the largest mass testing program out of the UK.”