By Samuel Indyk
Investing.com – Avacta Group (LON:AVCT) has announced that its 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.
The company partnered with Medusa Healthcare to obtain regulatory approval for the AffiDX test for consumer self-testing and has now received the CE Mark from a European Notified Body. The AIM-listed company has an exclusive arrangement with Medusa to commercialise the product globally.
The test will be marketed by Medusa under the brand name MeduFlow.
“This is an extremely important step forwards in the commercialisation of the AffiDX antigen test,” said Avacta Group Chief Executive Officer Dr Alastair Smith.
“As the pandemic progresses, the global antigen testing market is moving away from professional use antigen tests with increasing adoption of self-test products.
“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.”
Avacta’s AffiDX test uses a nasal swab and gives a result in 20 minutes. The test has shown to have sensitivity across a broad range of viral loads of 98% and a specificity of 99%.
The test was previously CE marked for professional use in the UK and EU in June 2021.
At 09:06GMT, shares in Avacta Group were trading higher by 18.5% at 124.20 pence per share.