Avacta, a clinical stage biopharmaceutical company developing diagnostics based on its Affimer and pre|CISION platforms, has announced that the AffiDX SARS-CoV-2 antigen lateral flow test has received a CE mark for use as a consumer self-test in the UK and EU.
Avacta partnered with Medusa Healthcare (Medusa) to obtain regulatory approval for the AffiDX antigen test for consumer self-testing and has now received the CE mark from a European Notified Body. Avacta has an exclusive arrangement with Medusa to commercialise the consumer self-test product globally.
The AffiDX SARS-CoV-2 antigen lateral flow self-test will be marketed by Medusa under the brand name “MeduFlow”.
The AffiDX SARS-CoV-2 antigen lateral flow test has been developed using Avacta’s Affimer platform to identify individuals with a higher viral load of the SARS-CoV-2 virus who are therefore more likely to infect others. The test, which uses a nasal swab that gives a result in 20 minutes, has been independently clinically validated at the Carlos III hospital in Madrid and shown to have a sensitivity across a broad range of viral loads of 98% and a specificity of 99%. The AffiDX antigen lateral flow test was CE marked for professional use in the UK and EU in June 2021.
Dr Alastair Smith, chief executive officer of Avacta Group, 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.
“Our partners at Medusa have rapidly obtained regulatory approval, and we look forward to working closely with them to provide consumers with reliable, high-quality tests that address this substantial market.”
