Medusa will market the AffiDX SARS-CoV-2 antigen lateral flow self-test under the brand name MeduFlow
The test received CE mark for professional use in the UK and EU in June this year. (Credit: Lela Maffie from Pixabay)
Avacta Group has secured a CE mark for the AffiDX SARS-CoV-2 antigen lateral flow test for use as a consumer self-test in the UK and EU.
Developed using Avacta’s proprietary Affimer platform, the test enables to identify individuals with a higher viral load of the SARS-CoV-2 virus, who could infect others.
The AffiDX SARS-CoV-2 antigen lateral flow test uses a simple, patient friendly nasal swab and has the capability to provide results in 20 minutes.
The test, which was validated at the Carlos III hospital in Madrid, received CE mark for professional use in the UK and EU in June this year.
Avacta Group chief executive Dr. 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.
To receive regulatory approval for the AffiDX antigen test for consumer self-testing, the clinical stage biopharmaceutical company has partnered with Medusa Healthcare.
Avacta holds an exclusive arrangement with Medusa for the commercialistion of the consumer self-test product.
Medusa will market the AffiDX SARS-CoV-2 antigen lateral flow self-test under the brand name MeduFlow.
Smith said: “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.”
Recently, Avacta announced that the AffiDX antigen lateral flow test is able to detect the Omicron variant of the SARS-CoV-2 virus.