Business
MHRA Confirms Registration of Lateral Flow Test
MHRA Confirms Registration of Lateral Flow Test.
About this update from Avacta Group Plc
[{"type":"text","content":"\n \n \n \n RNS Number : 9563A\n Avacta Group PLC\n 07 June 2021\n \n \n \n \n 7 June 2021\n \n \n Avacta Group plc\n \n \n \n \n \n (\"Avacta\" or \"the Group\" or \"the Company\")\n \n \n \n \n \n MHRA Confirms Registration of Avacta's AffiDX® SARS-CoV-2 Antigen Lateral Flow Test\n \n \n \n \n \n Avacta Group plc (AIM: AVCT), \n the developer of diagnostics and innovative cancer therapies based on its proprietary Affimer® and pre|CISION™ platforms, is pleased to announce that the MHRA has confirmed registration of Avacta's AffiDX® SARS-CoV-2 antigen lateral flow test allowing the Company to place the product on the market in the UK for professional use.\n \n \n \n \n \n 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 in April demonstrated 100% sensitivity for identifying infectious individuals with viral loads measured by PCR of Ct<27.\n \n \n \n \n \n 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 the MHRA allows the Company to sell the product in the UK for professional use and the Company expects product registration from a Competent Authority within the EU to follow shortly.\n \n \n \n \n \n Dr Alastair Smith, Chief Executive Officer of Avacta Group, commented:\n \n \n \"I am delighted to receive confirmation of the registration of the AffiDX® SARS-CoV-2 antigen test from the MHRA. It is a transformative milestone for Avacta's Diagnostics Division being the first CE marked product powered by the Affimer® platform that has been brought to market.\n \n \n \n \n \n \"The excellent 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.\n \n \n \n \n \n \n \"\n As part of the study the same clinical samples were tested with two leading, commercially available lateral flow antigen tests, and the data show that the AffiDx® test has superior clinical sensitivity across ...