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Innova Nabs CE Mark for Self-Testing for SARS-CoV-2 Antigen Test

NEW YORK – California diagnostic firm Innova Medical Group announced on Wednesday that its Innova SARS-CoV-2 Antigen Rapid Qualitative Test has received CE marking for self-testing.

The lateral flow immunochromatographic test has been used in the UK since 2020 after receiving an Exceptional Use Authorization under the country's Medicines and Healthcare products Regulatory Agency, which was extended in 2021. The assay was also provided to the UK population by the National Health Security Agency as part of the agency's test-and-trace program, the company said in a statement.

It has been approved for distribution in 18 countries for both point-of-care testing and self-testing, the Pasadena-based firm added. In June 2021, the US Food and Drug Administration requested Innova stop selling the test and warned the public against its use due to concerns about its performance.