Avacta Group plc, the developer of diagnostics and innovative cancer therapies based on its proprietary Affimer® and pre|CISION™ platforms, announced that it 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. A high viral load makes an individual more likely to infect others. The clinical data for Avacta’s AffiDX® SARS-CoV-2 antigen lateral flow test reported 20 April 2021, demonstrated 100% sensitivity for identifying infectious individuals with viral loads measured by 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. The Company is progressing multiple commercial opportunities with distributors and end-users in Europe and this product registration is the key final step towards commercialization.
Dr. Alastair Smith, Chief Executive Officer of Avacta Group, commented: “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 commercialization milestone.”
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