Avacta granted EU approval for Covid-19 test

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Listed biotechnology business Avacta Group has been granted approval to market its Covid-19 lateral flow test for professional use in the EU.

The company has received notice of registration of its AffiDX SARS-CoV-2 antigen lateral flow test, enabling it to place the product on the market in all 27 countries of the EU for professional use. 

It follows on from the UK approval for the test secured earlier this month (June 2021).

Avacta, who has sites in Wetherby and Cambridge, is progressing multiple commercial opportunities with distributors and end users in Europe, with the product registration said to be the key final step towards commercialisation.

Dr Alastair Smith, chief executive at 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.

“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.”

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