Corporate News

VISITECT® COVID-19 antigen test self-test submission update

06 September 2021

All supporting data and documentation now submitted to Omega’s European Notified Body

Omega (AIM: ODX), the medical diagnostics company focused on CD4, infectious diseases and food sensitivity, announces that all of the supporting data and documentation relating to its submission for CE marking for self-test use for the VISITECT® COVID-19 antigen test have been filed with its European Notified Body. The submission process has been running in parallel with the Useability Study conducted by Ulster University since mid-July and the conclusion of the Ulster study was the final step in this 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. 

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.

Colin King, CEO of Omega, said: "As a result of a lot of hard work by our team and Ulster University, we are very pleased to have submitted all of the information required for self-test use approval for our VISITECT® COVID-19 antigen test. Once approval is granted, we anticipate strong demand for a UK developed and manufactured product. 

“Furthermore, we believe we have a high-quality, high-performance product with significant global appeal, including the US market, due to that market’s size and high barriers to entry.



Omega Diagnostics Group PLC
Colin King, Chief Executive via Walbrook PR
Kieron Harbinson, Group Finance Director  
finnCap Ltd Tel: 020 7220 0500
Geoff Nash/Edward Whiley (Corporate Finance)  
Alice Lane (ECM)  
Walbrook PR Limited Tel: 020 7933 8780 or [email protected]
Paul McManus Mob: 07980 541 893
Lianne Cawthorne Mob: 07584 391 303


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