Avacta Group, the developer of diagnostics and innovative cancer therapies based on its proprietary Affimer® and pre|CISION™ platforms, has received notice of registration of its AffiDX® SARS-CoV-2 antigen lateral flow test in the EU allowing the company to market the product in the EU for professional use.
Lateral flow antigen tests are intended to provide a cost effective and rapid means of identifying individuals with a high viral load that means they are more likely to infect others. The clinical data for Avacta’s AffiDX SARS-CoV-2 antigen lateral flow test reported 20 April 2021, demonstrated 100% sensitivity for identifying infectious individuals with viral loads measured by PCR of Ct<27.
Dr Alastair Smith, Chief Executive Officer of Avacta Group, commented: “The EU is an important market for us, and the product registration is a key commercialisation milestone.
“The results of the recent clinical evaluation of the test at a clinical site in Europe demonstrate the test has excellent sensitivity across a range of viral loads, which would be considered infectious. This excellent performance and ease of nasal sampling, coupled with the fact that the AffiDX test is has been developed in the UK, is based on UK technology and is manufactured in the UK, are huge selling points for customers in Europe.”
- For more information, visit: avacta.com