Omega Diagnostics has achieved the Certificate d'Europe (CE) certification on its Visitect Covid-19 antigen test for self use.
It provides an accurate rapid test for the detection of the nucleoprotein of the virus in nasal swabs only.
Independent, multi-centre validations, showed a sensitivity of 93.2%, based on 103 samples with cycle threshold values less than 25, and 97.8% specificity, based on 230 RT-qPCR negative samples.
The company remains in discussions with commercial partners about how best to service the European market and other territories that recognise the CE mark.
Omega’s commercial offering will be via partners and distributors, and not through a direct-to-consumer strategy.
The CE mark certificate is conditional upon the submission of additional data and follow-up reports by 31 March 2022 and Omega is working with its external study centres to ensure this deadline is met.
Omega remains in the review process under Corona Test Device Approval (CTDA) regulations, which were introduced on 1 November.
Further field study data has been recently requested. Omega is seeking this information from external parties but this may not be available prior to the current extended deadline for submission of 10 February 2022.
Jag Grewal, chief executive at Omega, commented: “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.”
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