Avacta Group has announced that the Declaration of Conformity for CE mark of its AffiDX SARS-CoV-2 antigen rapid test for professional use has been submitted to the Medicines and Healthcare products Regulatory Agency (“MHRA”) through its partner Mologic.

Avacta has developed a SARS-CoV-2 antigen lateral flow test using its Affimer platform to detect the Coronavirus spike antigen and recently announced data from a clinical study on 98 positive COVID-19 samples that demonstrate excellent performance in identifying the SARS-CoV-2 virus across a broad range of viral loads.

These data have now been combined with stability and other performance data and a submission of the Declaration of Conformity for CE marking of the AffiDX SARS-CoV-2 antigen lateral flow test for professional use has now been made to the MHRA. 

The Group expects to receive confirmation of the registration of the AffiDX in-vitro diagnostic device in the coming days, which will allow the Group to immediately place the test on the market.

Dr Alastair Smith, chief executive of Avacta Group said: “I am absolutely delighted to have reached this significant milestone for the Diagnostics Division and Avacta Group.

“I am very proud of the quality and performance of Avacta’s AffiDX antigen test. As part of the recent clinical study the same clinical samples were tested with two leading, commercially available lateral flow antigen tests, and the data show that the AffiDX test had better clinical sensitivity across the range of Ct values tested 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 the interest that we have received for it from potential commercial partners, distributors and end users. We are looking forward to receiving confirmation of the registration from MHRA in the coming days allowing the Group to immediately place the test on the market.”