Registration of SARS-CoV-2 antigen lateral flow test in the EU
Avacta Group 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 on 20 April 2021, demonstrated 100% sensitivity for identifying infectious individuals with viral loads measured by polymerase chain reaction (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. Avacta is progressing multiple commercial opportunities with distributors and end users in Europe and this product registration is the key final step towards commercialisation.