Conflicting Messages About Innova’s Rapid COVID-19 Test

Innova’s COVID-19 antigen test has been cleared by MHRA, nearly a week after FDA gave a harsh rebuke of the diagnostic.

Omar Ford

June 18, 2021

2 Min Read

Innova’s COVID-19 antigen test has been cleared and has had its authorization extended by the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA). This measure comes hot on the heels of FDA going in the opposite direction, by urging the public to stop using the test for diagnostic use.

The MHRA said it found issues with the company’s test.

“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 release. “We have now concluded our review of the risk assessment and are satisfied that no further action is necessary or advisable at this time. This has allowed us to extend the EUA to allow [the] ongoing supply of these lateral flow devices over the coming months.”

FDA was brutal with its instructions on how to deal with the test. In recommendations on how to deal with the diagnostic, the federal agency said, “destroy the tests by placing them in the trash or return the tests to the company using the FedEx return label that was included with the recall letter that was sent to customers.”

Innova recalled the test on April 23, and FDA considers it to be a Class I recall, the most serious type of recall.

The test’s acceptance by MHRA comes at a time COVID-19 rates are surging in Europe because of the Delta variant. Prime Minister Boris Johnson delayed plans to lift all COVID-19 restrictions on June 21, because of the variant according to a report from CNN.

Instead, the eradication of restrictions is set to occur four weeks later on July 19. The delay will help the government to accelerate giving second vaccinations to those most vulnerable, CNN reported.

About the Author(s)

Omar Ford

Omar Ford is MD+DI's Editor-in-Chief. You can reach him at [email protected].


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