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Disease testing group Omega Diagnostics said all supporting data and documents related to a submission for CE marking for self-test use for a Covid-19 antigen test had been filed.
The submission process had been running in parallel with a useability study conducted by Ulster University since mid-July and the conclusion of the Ulster study was the final step in the process.
'The test is already CE marked for professional-use and once approved would allow the test to be sold in Europe for home-use as well,' the company said.
'As the global market for antigen testing develops, the company believes self-test approval will be a key requirement, as has already been seen in the UK.'
'The submission is already under review by the notified body and the company will provide a further update on the process as it concludes.'