By Samuel Indyk
Investing.com – Omega Diagnostics (LON:ODX) has today announced that all 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 run alongside 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 it is approved, the test would be allowed to be sold in Europe for home use as well.
“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,” said Omega Diagnostics CEO Colin King.
The company believes that self-test approval will become a key requirement as the global market for antigen testing develops, similar to what has been observed in the UK. The submission is currently under review by the Notified Body and Omega said they will provide an update on the process as it concludes.
“Once approval is granted, we anticipate strong demand for a UK developed and manufactured product,” King added.
“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.”
At 09:19BST, shares in Omega Diagnostics were trading lower by 1% at 52.88 pence per share.