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 place the product on the market in all 27 countries of the EU for professional use.
Lateral flow antigen tests are designed to provide a rapid means of identifying individuals with a high viral load that are more likely to infect others. The clinical data for Avacta’s test reported 20 April 2021, demonstrated 100% sensitivity for identifying infectious individuals with viral loads measured by PCR of Ct<27.
The product registration in the EU allows the company to sell the test in the EU for professional use. Its progressing multiple commercial opportunities with distributors and end users in Europe and this product registration is the key final step towards commercialisation.
Dr Alastair Smith, CEO of Avacta Group, commented: “We are delighted to receive confirmation of the registration of the AffiDX SARS-CoV-2 antigen test in the EU. 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.
“Lateral flow tests have a crucial role to play in helping our societies and economies return to normal, and I am confident that the AffiDX test will now play a significant part in this process.”