The Aim-quoted, specialist medical diagnostics company said the offering will provide consumers with an accurate rapid test only using nasal swabs – and has been found to have achieved sensitivity of 93.2 per cent.
Omega also said it remains in talks with commercial partners about how best to service the European market and other territories that recognise the CE mark, and its commercial offering will be via business-to-business partners and distributors, not direct to consumers.
It added that the CE Mark certificate is conditional on submitting further information by March 31, while it is still in the review process under Coronavirus Test Device Approvals (CTDA) regulations, which were introduced in the UK last year.
Chief executive Jag Grewal hailed the firm reaching the “milestone” of CE Mark approval. However, he added: “It is frustrating that our test is still awaiting approval under CTDA regulations for sale of the professional-use test in the UK. We will now look to begin the process of filing for approval to sell our home-use product in the UK. In the meantime, we look forward to working with prospective partners to determine the best route to market.”
The update from the firm, whose remit also includes testing regarding food intolerance, allergies, and the immune systems of people with HIV, comes after it said it was in discussions regarding a potential equity fundraising, but “has significant cash resources”.
It had also in November said Covid-19 revenues “remain extremely difficult... and are impacted by the timing of pending regulatory approvals being granted”.