Avacta to sell rapid Covid-19 test in EU following registration
Diagnostics and cancer therapies developer Avacta Group has received notice of registration of its ‘AffiDX’ SARS-CoV-2 antigen lateral flow test in the European Union, allowing it to place the product on the market for professional use in all 27 countries of the EU.
The AIM-traded firm said 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 with Covid-19.
It said the clinical data for its AffiDX test, reported 20 April, demonstrated 100% sensitivity for identifying infectious individuals with viral loads measured by PCR of Ct<27.
Avacta said it was having 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 would allow it to sell the product in all member countries for professional use.
It said it was progressing multiple commercial opportunities with distributors and end users in Europe, with the product registration being the “key final step” towards commercialisation.
“We are delighted to receive confirmation of the registration of the AffiDX SARS-CoV-2 antigen test in the EU,” said chief executive officer Dr Alastair Smith.
“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.”
Dr Smith said that “excellent performance” and “ease of nasal sampling”, coupled with the fact that the AffiDX was developed in the UK, based on UK technology and manufactured in the UK, were “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.”
At 1155 BST, shares in Avacta Group were up 10.82% at 242.7p.