Medical test manufacturer Omega Diagnostics has submitted evidence in support of European approval for the use of its Visitect Covid test for home use.
The antigen test, which determines whether an individual is currently infected with the virus, is already approved for professional use. If its latest submission is successful, it will then be CE marked for sale in Europe as a self-testing kit.
The submission process has run alongside a usability study conducted by Ulster University since mid-July. The conclusion of the Ulster study was the final step in the CE self-test submission.
“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,” chief executive Colin King said. “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.”
Following publication of the Scottish firm’s year-end results in July, Mr King said the AIM-listed company’s high-profile Covid testing business remains “very much dependent” on government authorities. Among its various lines of Covid business is a partnership with Bedfordshire-based Mologic that has encountered protracted delays in the UK approval process.
READ MORE: Omega shares fall on Mologic test woes
The test from the Mologic partnership is one of several under consideration by the Department of Health and Social Care (DHSC) in its fight to keep the virus under control. Omega’s headquarters in Alva will be one of the sites producing tests on behalf of the DHSC as part of a potentially lucrative contract that could be worth up to £374 million over the lifetime of the agreement.
Shares in Omega finished yesterday’s trading up 0.5p at 53.5p.