Omega gets CE-marking for Covid-19 test, working on UK approval
Updated : 15:39
Medical diagnostics specialist Omega has successfully CE-marked its ‘Visitect’ Covid-19 antigen test for self-test use, it announced on Thursday.
The AIM-traded firm said the test would provide consumers with an accurate rapid test for the detection of the nucleoprotein of the SARS-CoV-2 virus in nasal swabs only.
It said the test had “excellent” performance characteristics following independent multi-centre validations, with sensitivity of 93.2% based on 103 samples with cycle threshold (Ct) values of less than 25, and 97.8% specificity, based on 230 RT-qPCR negative samples.
The company said it was in discussion with commercial partners over how best to service the European market and other territories that recognise the CE-mark.
Omega said its commercial offering would be via business partners and distributors, and not through a direct-to-consumer strategy.
The CE-mark certificate is conditional on the submission of additional data and follow-up reports by 31 March, which Omega said it was working with its external study centres to ensure is met.
It a;sp remained in the review process under the UK’s Coronavirus Test Device Approvals (CTDA) regulations, which were introduced in November.
Further field study data was recently requested, and Omega said it was seeking that information from external parties, but warned it might not be available before the current extended deadline for submission on 10 February.
“We are delighted to have reached this milestone, achieving CE-mark for our Visitect Covid-19 antigen test for the home-use market,” said chief executive officer Jag Grewal.
“It is frustrating that our test is still awaiting approval under CTDA regulations for sale of the professional-use test in the UK.”
Grewal said the company was looking to start the process of filing for approval to sell its home-use product in the UK.
“In the meantime, we look forward to working with prospective partners to determine the best route to market.”
At 1522 GMT, shares in Omega Diagnostics Group were up 15.87% at 11.01p.