Omega Diagnostics (ODX ) said it is making progress to gain regulatory approval for its VISITECT® COVID-19 antigen test as a self-test product and for US professional use.
The medical diagnostics company said it has initiated the process of engagement with its European Notified Body seeking CE marking of the rapid point-of-care diagnostic VISITECT® COVID-19 antigen test for the detection of active COVID-19 infections as a self-test.
The Company said it is in the process of agreeing to the protocols required for utilisation studies. The test is already CE marked for professional-use and the Company is targeting approval by the end of July to allow the test to be sold in Europe for home-use as well.
As the global market for antigen testing develops the Company believes self-test approval will be a key product differentiator, as has already been seen in the UK, it told investors.
Shares in Omega Diagnostics were trading 0.83% higher today at 61p following the news.
Meanwhile, Omega said its technology partner, Mologic Ltd ("Mologic") has successfully completed the necessary performance studies required for regulatory approval in the US.
It said it is in the final stages of preparing a submission to the U.S. FDA requesting Emergency Use Authorisation (EUA) for its rapid point-of-care COVID-19 antigen test, for use under both the Omega's VISITECT® brand and Global Access Diagnostics brand.
Commenting on the progress, Colin King, Chief Executive of Omega Diagnostics said:
"I am pleased with the progress we are making to gain regulatory approval, both for our VISITECT self-test product and for US professional use. Both routes offer potentially significant opportunities as we believe we have a high quality product with global appeal."
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