Avacta’s (LON: AVCT) shares are rallying on Friday after it received notice of registration of its AffiDX SARS-CoV-2 antigen lateral flow test in the EU.
The registration allows the company to place the product on the market in all 27 EU countries for professional use.
Earlier this week, the MHRA confirmed the registration of Avacta’s AffiDX, meaning it can be marketed for professional use in the UK.
The clinical data for the lateral flow test demonstrated 100% sensitivity for identifying infectious individuals with viral loads measured by PCR of Ct<27.
Avacta is in commercial discussions with distributors and end-user customers in countries that accept the CE mark for in vitro diagnostic products. The products registration is “the key final step towards commercialisation,” said Avacta.
Dr Alastair Smith, CEO of Avacta Group, commented: “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.”
Avacta shares are up 13.97% at 249.6p at the time of writing.
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