Avacta lateral flow test receives CE mark for consumer self-testing

pharmafile | December 22, 2021 | News story | Research and Development  

Avacta Group plc, a clinical stage biopharmaceutical company developing innovative cancer therapies and powerful diagnostics based on its proprietary Affimer® and pre|CISION™ platforms, partnered with Medusa Healthcare (Medusa) to obtain regulatory approval for the AffiDX® SARS-CoV-2 antigen lateral flow test. The company has announced that the AffiDX antigen test for consumer self-testing has received a CE mark for use in the UK and EU.

Avacta has an exclusive arrangement with Medusa to commercialise the consumer self-test product globally. The lateral flow self-test will be marketed by Medusa under the name MeduFlow.

 “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,” Dr Alastair Smith, Chief Executive of Avacta Group, commented. “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 news arrives alongside record numbers of positive coronavirus cases, and over 60,000 positive new Omicron cases confirmed in the UK, as of 21 December. 

“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,” Alastair Smith shared.

The AffiDX SARS-CoV-2 antigen lateral flow test has been developed using Avacta’s proprietary Affimer platform. The test identifies individuals with a higher viral load of the SARS-CoV-2 virus, who are therefore more likely to infect others. AffiDX gives results in 20 minutes, and has shown efficacy in the Carlos III hospital in Madrid, showing a sensitivity across a broad range of viral loads of 98%, and a specificity of 99%.

Ana Ovey

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