Avacta Group has obtained CE mark for its AffiDX SARS-CoV-2 antigen lateral flow test from a European Notified Body to be used as a consumer self-test in the European Union (EU) and the UK.
The company obtained the regulatory approval for the test in partnership with Medusa Healthcare.
It has also entered into an exclusive agreement with Medusa to commercialise the AffiDX SARS-CoV-2 antigen lateral flow consumer self-test across the world, under the brand name ‘MeduFlow’.
Developed using Avacta’s Affimer platform, the new flow test is intended to detect people with a high SARS-CoV-2 viral load and more likely to infect others.
It uses a nasal swab sample and provides results in 20 minutes.
Avacta Group CEO Alastair Smith said: “This is an extremely important step forwards in the commercialisation of the AffiDX antigen test.
“As the pandemic progresses, the global antigen testing market is moving away from professional use antigen tests with increasing adoption of self-test products.
“The AffiDX test is the first UK-developed SARS-CoV-2 antigen test that has received a CE mark for self-testing which, coupled with the fact that it is based on innovative UK technology and is manufactured in the UK are important selling points for customers in the UK, EU and elsewhere.”
The company stated that the AffiDX SARS-CoV-2 antigen lateral flow test has been clinically evaluated at the Carlos III hospital in Madrid, showing 98% sensitivity across a wide range of viral loads and 99% specificity.
In June this year, the test received CE mark for professional use in the UK and EU.