By Samuel Indyk
Investing.com – Omega Diagnostics (LON:ODX) has announced it has successfully CE-Marked is VISITECT COVID-19 antigen test for self-use.
The test will now allow consumers to accurately detect the nucleoprotein of the SARS-CoV-2 virus in nasal swabs only.
The AIM-listed company said it remains in discussions with commercial partners about how best to service the European market and other territories that recognise the CE-Mark. Omega said its commercial offering will be via B2B partners and distributors and not a direct-to-consumer strategy.
The CE-Mark certificate is conditional upon the submissions of additional data and follow-up reports by 31st March 2022. Omega said it is working closely with its external study centres to ensure this deadline is met.
On the UK front, the company confirmed it remains in the review process under the recently introduced CTDA regulations. Further field study data has been requested and the company is seeking the information from external parties, but this data may not be available before the current extended deadline for submission of 10th 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 Omega Diagnostics CEO 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.”
At 08:40GMT, shares in Omega Diagnostics were trading higher by 16.6% at 11.07 pence per share.