3rd Feb 2022 14:35
Omega Diagnostics Group PLC - Alva, Scotland-based medical diagnostics company - Wins CE mark for Visitect Covid-19 antigen self-test. The CE mark must be affixed to many products before they are permitted to be sold on the European market. Discussing with commercial partners how to best capitalise on the European market and other territories that recognise the CE mark. The CE mark certificate is conditional upon the providing of additional data and reports by Omega before the deadline of March 31.
Omega is still awaiting approval for its lateral flow test in the UK under new Coronavirus Test Device Approvals regulations, which were introduced in November. It will be unable to sell professional-use tests in the UK until it receives approval, which requires further field study data. The company has requested the data from external parties, but said it may not be available before the submission deadline of February 10.
"We will now look to begin the process of filing for approval to sell our home-use product in the UK. In the meantime, we look forward to working with prospective partners to determine the best route to market," says Chief Executive Officer Jag Grewal.
Current stock price: 10.82 pence, up 14% on Thursday
12-month change: down 84%
By Elizabeth Winter; [email protected]
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