Avacta secures EU registration for its new, rapid test for COVID-19
Biotech company, Avacta Group, has now registered its AffiDX® SARS-CoV-2 antigen lateral flow test in the EU, allowing the firm 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 COVID-19 viral load that means they are more likely to infect others.
Wetherby-based Avacta says it 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 is the key final step towards commercialisation.
News of the registration sent Avacta’s share price up from 227p late this morning up to 247p this afternoon.
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 the AffiDX® test will now play a significant part in this process.”