Avacta, the developer of diagnostics and innovative cancer therapies based on its 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 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.

Avacta has multiple ongoing commercial discussions with distributors and end-user customers in countries that accept the CE mark for in vitro diagnostic products. The product registration by a Competent Authority in the EU allows the company to sell the product in the EU for professional use. The company is 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, chief executive officer of Avacta Group, said: “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.”