{"id":86984,"title":"Omega Diagnostics Gp (ODX.L) VISITECT ® COVID-19 antigen test self-test submission update","publisher":"Share Talk","author":"sharetalk","published":"2021-09-06T06:45:01+00:00","modified":"2021-09-06T06:45:01+00:00","canonical_url":"https://www.share-talk.com/omega-diagnostics-gp-odx-l-visitect-covid-19-antigen-test-self-test-submission-update/","markdown_url":"https://www.share-talk.com/omega-diagnostics-gp-odx-l-visitect-covid-19-antigen-test-self-test-submission-update.md","json_url":"https://www.share-talk.com/omega-diagnostics-gp-odx-l-visitect-covid-19-antigen-test-self-test-submission-update.json","category":"Healthcare","categories":["Healthcare","Pharmaceutical"],"tags":["Abingdon Health","Administration","Antigen Test","china","Colin King","Contract","COVID-19","David Grouse","diagnostic","diseases","Drug","Food","infectious","Manufacturing","Medical","Mologic Ltd","ODX","Omega Diagnostics","Omega Diagnostics Gp","Rapid Test","scientists","Screen4","UK Government","UK-RTC","University of Oxford"],"featured_image":"https://i0.wp.com/www.share-talk.com/wp-content/uploads/2023/11/Stencil-Google-Chrome-2023-04-19-at-2.47.43-PM.jpeg?fit=1231%2C615&ssl=1","format":"news","language":"en-GB","content":"**All supporting data and documentation now submitted to Omega’s European Notified Body**\n\n**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.\n\nAs 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.\n\n**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.\n\n“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. ”\n\n**Contacts:**\n\n**Omega Diagnostics Group PLC**\n\n[www.omegadiagnostics.com](http://www.omegadiagnostics.com)\n\n**Colin King, Chief Executive Officer**\n\n**via Walbrook PR**\n\n**Chris Lea, Chief Financial Officer**"}