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UK Government Extends Authorization for Innova Medical SARS-CoV-2 Antigen Test

NEW YORK ─ The UK government's Medicines and Healthcare Products Regulatory Agency, or MHRA, announced on Thursday that it has extended to Aug. 28 an Exceptional Use Authorization for National Health Service test-and-trace lateral flow devices that are part of its asymptomatic testing program.

The extension covers a lateral flow test from Innova Medical Group, which the US Food and Drug Administration recently warned the public not to use.

The lateral flow devices are authorized for detecting positive cases of COVID-19 in asymptomatic people and can be used for one-off testing prior to an activity to reduce risks and also for outbreak testing, MHRA said.

Its decision to extend the authorization timeline comes in the wake of "a satisfactory outcome of a review" initiated because the FDA recently issued a warning about Innova's test, MHRA said in a statement.

Innova is the supplier of NHS test-and-trace lateral flow tests, and the UK's Department of Health and Social Care has responsibility as the legal manufacturer for the products used in the UK.

"Our priority is to ensure patients and the public have access to safe and effective medical devices and tests," Graeme Tunbridge, MHRA director of devices, said in a statement. "Following our normal process to investigate any product concern, the MHRA immediately began reviewing all available information. ... We have now concluded our review of the risk assessment and are satisfied that no further action is necessary or advisable at this time."

The FDA last week requested that Innova stop sales of its SARS-CoV-2 Antigen Rapid Qualitative Test and warned the public against using the test, citing significant concerns about its performance and the potential for false-negative or false-positive results.

The UK government's Porton Down testing facility, where newly developed rapid SARS-CoV-2 tests are validated, has approved the use of the lateral flow antigen test developed by Innova, which has reportedly supplied the UK government with more than 1 billion rapid tests under contracts worth more than £3 billion ($4.23 billion).

Bedford, UK-based lateral flow test developer Mologic announced this week that it is suing the UK government, whose laboratory failed its SARS-CoV-2 antigen test in internal testing.

Joe Fitchett, the company's medical director, recently told 360Dx that the approval of tests by the UK government's validation facility "doesn't mean they are good or that they work." One example of that is the FDA's warning about Innova's tests, the backbone of the UK's rapid antigen testing strategy, he added.