The UK medicines regulator is carrying out checks on rapid Covid-19 tests from the government’s main supplier Innova, following a stinging rebuke of the product from the US Food and Drug Administration.
FDA officials raised concerns on Thursday that Innova was distributing its lateral flow tests in the US despite not having had the product approved by the regulator.
The agency also called into question the data underpinning Innova’s application for regulatory approval, saying it was an exact match of data provided by “other [test] manufacturers”.
The UK government is Innova’s biggest client worldwide, having handed the company more than £2bn in contracts. In the UK, Innova’s rapid-fire antigen tests are NHS Test and Trace-branded and used as part of a large asymptomatic testing programme in schools and workplaces.
Graeme Tunbridge, the director of devices for the Medicines and Healthcare Products Regulatory Agency, said the UK regulator, which granted Innova emergency authorisation in December last year, was “aware of the FDA communication” and carrying out checks accordingly.
“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,” Tunbridge added. Innova’s emergency approval to distribute their test in the UK is set to expire on June 22, unless it is renewed by the MHRA.
In May, Innova announced plans to open a production facility in Wales, creating 300 jobs. Dan Elliott, the company’s CEO, told the Financial Times at the time: “We’ve been a good partner to the government, the government’s been a good partner to us.”
But the tests have been greeted with scepticism by some scientists, who question their accuracy and value, with studies showing lateral flow devices only capture between 40 and 70 per cent of the Covid-19 cases picked up by the more widely used PCR test.
Following an inspection of Innova’s Californian headquarters in March and April, the FDA said it discovered Innova’s rapid antigen test “[had] been distributed in the United States without marketing approval, clearance, or authorization from FDA” and issued a recall of all products.
Innova confirmed the company was recalling products issued to “employees, clinical studies and some customers for evaluations purposes”.
“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,” the company said. “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.”
The agency also questioned the origin of the data Innova had handed the regulator as part of ongoing attempts to gain emergency approval in the US, adding that the “data reliability and accuracy issues” could “present a serious risk to public health”.
“The clinical study data you submitted in your EUA request for the SARS-COV-2 Antigen Rapid Qualitative Test was identical to data previously provided by other manufacturers in their separate EUA requests,” said the FDA in a letter to Innova on Thursday.