Omega Diagnostics (ODX) has successfully filed all supporting data and documentation required for the self-test use approval of the Group’s VISITECT® COVID-19 antigen test.
The medical diagnostics firm focused on CD4, infectious diseases and food sensitivity, said all supporting data and documentation relating to the company’s submission for CE marking for self-test use for the VISITECT® test has now been submitted to 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 this was the final step in this process.
The VISITECT® COVID-19 antigen test is already CE marked for professional use and once it is approved, the test would be allowed to be sold in Europe for home use as well, it explained.
As the global market for antigen testing develops the Company believes self-test approval will be a key product differentiator, as has already been seen in the UK, Omega told investors.
The Company outlined that the submission is already under review by the European Notified Body and that the Company will provide a further update on the process as it concludes.
Colin King, Chief Executive of Omega, commented: "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."
Back in July, the Company told investors that a submission had been filed to the US FDA requesting Emergency Use Authorization (EUA) for its rapid point-of-care COVID-19 antigen test for use under both its VISITECT® brand and Global Access Diagnostics (GAD) brand.
The submission, which followed the completion of Omega’s US performance studies, was made by its technology partner and developer of lateral flow and rapid diagnostics, Mologic.
Omega announced in early June 2021 that it was making progress to gain regulatory approval for its VISITECT® COVID-19 antigen test as a self-test product and for US professional use.
At the time, the company said it had already initiated the process of engagement with its European Notified Body to seek a CE mark for its rapid point-of-care diagnostic VISITECT® COVID-19 antigen test for the detection of active COVID-19 infections as a self-test.
Omega also added that it was in the final stages of preparing a submission to the U.S. FDA requested Emergency Use Authorisation (EUA) for the rapid point-of-care COVID-19 antigen test, for use under both its VISITECT® brand and Global Access Diagnostics brand.
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