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Omega Diagnostics files for CE-mark on Covid-19 self-test
6th Sep 2021 12:04
(Sharecast News) - Medical diagnostics company Omega announced on Monday that all of the supporting data and documentation relating to its submission for CE-marking for self-test use of its 'Visitect' Covid-19 antigen test had been filed with its European notified body.
The AIM-traded firm said the submission process had been running in parallel with the useability study conducted by Ulster University since mid-July, with the conclusion of the Ulster study being the final step in the process.
It said the test was already CE-marked for professional-use, and once approved, would allow it to be sold in Europe for home-use as well.
As the global market for antigen testing develops, the company said it believed self-test approval would be a "key" requirement, as had already been seen in the UK.
The submission was already under review by the notified body, the board 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," said chief executive officer Colin King.
"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 United States market, due to that market's size and high barriers to entry."
At 1542 BST, shares in Omega Diagnostics Group were up 2.64% at 54.4p.
The AIM-traded firm said the submission process had been running in parallel with the useability study conducted by Ulster University since mid-July, with the conclusion of the Ulster study being the final step in the process.
It said the test was already CE-marked for professional-use, and once approved, would allow it to be sold in Europe for home-use as well.
As the global market for antigen testing develops, the company said it believed self-test approval would be a "key" requirement, as had already been seen in the UK.
The submission was already under review by the notified body, the board 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," said chief executive officer Colin King.
"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 United States market, due to that market's size and high barriers to entry."
At 1542 BST, shares in Omega Diagnostics Group were up 2.64% at 54.4p.