Pasadena, Calif.-based Innova Medical’s SARS-CoV-2 antigen rapid qualitative test has received a CE mark for use in self-testing.

Data from 1.7 million tests from independent studies in lab and field settings demonstrated that rapid antigen test is “highly effective in detecting infected individuals who are considered infectious to others,” the company said.

The test has been widely used in the UK under an emergency use authorization since late 2020. Although the UK is no longer part of the European Union, it is continuing to accept CE mark accreditation, Innova Medical noted.