Avacta Group has announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed registration of the AffiDX SARS-CoV-2 antigen lateral-flow test, so it can place the product on the market in the UK 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 in April 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 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.
Dr Alastair Smith, Chief Executive Officer of Avacta Group, commented: “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.
“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. 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 the range of samples and in particular at lower viral loads.
“We are very excited by the potential of this high-quality SARS-CoV-2 rapid antigen test and by the interest it has already attracted from potential commercial partners and distributors. We will continue to focus on its commercial roll-out and manufacturing scale-up to meet demand.
“Lateral flow tests have a crucial role to play in helping our society and economy return to normal, and I am confident that the AffiDX test will now play a significant part in this process.”