22nd Dec 2021 10:31
(Alliance News) - Avacta Group PLC announced on Wednesday its AffiDX Covid-19 antigen lateral flow test has received a CE mark for consumer self-test use in the UK and EU.
Shares in Avacta were up 20% at 127.20 pence on Wednesday morning in London following the announcement.
The AffiDX test was previously CE marked for professional use in the UK and EU in June 2021. A CE mark signifies that products sold in the European Economic Area have been assessed to meet high safety, health, and environmental protection requirements.
The Leeds-based biopharmaceutical company partnered with Medusa Healthcare to obtain regulatory approval for the tests and has an arrangement with the company to commercialise the product globally.
The tests will be marketed by Medusa Healthcare under the brand name "MeduFlow". Medusa Healthcare is a subsidiary of Medusa 19 Ltd, a Manchester-based scientific equipment supplier.
The AffiDX test were developed to identify individuals with a higher viral load of the Covid virus and they were clinically validated at the Carlos III hospital in Madrid.
Chief Executive Alastair Smith added that the AffiDX tests were the first UK-developed antigen tests to receive a CE mark for self-testing.
By Heather Rydings; [email protected]
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