Omega Diagnostics (LON: ODX) shares are climbing on Monday after the company said it has filed the supporting data and documentation relating to its submission for CE marking for self-test use for the VISITECT COVID-19 test have been filed with the European Notified Body.
The submission process has been running in parallel with a usability study conducted by Ulster University since mid-July, and the conclusion of the Ulster study was the final step in this process.
The VISITECT COVID-19 antigen test is already CE marked for professional use. Once approved, it will be for sale in Europe for home use as well.
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.”
The company's shares have risen over 1% to 53.6p following the announcement.
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