Wetherby firm given green light to market accurate new Covid test
Drug developer Avacta has been given the green light for its Covid-19 test, which will now marketed in the UK for professional use.
The Wetherby-based firm said approval by the government’s Medicines and Healthcare products Regulatory Agency (MHRA) was a “transformative milestone” for its diagnostics division.
Avacta said its AffiDX SARS-CoV-2 antigen lateral flow test will provide a cost-effective and rapid means of identifying individuals with a high viral load, which means they are more likely to infect others. In trials it demonstrated 100 per cent sensitivity for identifying infectious people with high viral loads.
Following the MHRA registration, Avacta expects product registration from a competent authority within the EU to follow shortly.
Speaking of the registration, Dr Alastair Smith, chief executive officer of Avacta Group, said: “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.”
He added: “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.”