Omega Diagnostics Group PLC - London-based medical diagnostics company - Seeks CE marking to allow the Visitect Covid-19 antigen test to be sold for home-use in Europe by late July. Visitect test already CE marked for professional-use. The company believes "self-test approval will be a key product differentiator" in Europe, as it has been in the UK.
Omega's technology partner, Mologic Ltd, completes the performance studies needed for its tests to achieve regulator approval for professional use in the US. Mologic hits final stages to submit its rapid point-of-care Covid-19 antigen test for emergency use authorization by the US Food & Drug Administration. In the US, Mologic's test will be used under the Omega's Visitect test and Global Access Diagnostics brand.
Chief Executive Officer of Omega, Colin King says: "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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By Scarlett Butler; scarlettbutler@alliancenews.com
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