Avacta Group has announced that the MHRA has registered its AffiDX SARS-CoV-2 antigen lateral flow test. MHRA registration enables Avecta to market the product for professional use in the UK.
Antigen lateral flow tests are used as a quick, cost-effective means of identifying patients with a high viral load that increases the risk of spreading infection. Clinical data for the AffiDX test showed 100 per cent sensitivity in identifying infectious people with viral loads of Ct<27, as measured by PCR.
In addition to MHRA registration, Avacta also anticipates that it will shortly receive registration for the AffiDX SARS-CoV-2 test from a competent authority within the EU.
Avacta Group CEO Dr Alastair Smith said: “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.”