Avacta Group, the developer of Affimer biotherapeutics and reagents, has shipped Affimer reagents for SARS-COV-2 antigen testing to its diagnostic test development partners. The Group recently reported that it had generated multiple, highly specific Affimer reagents that bind the SARS-COV-2 viral antigen and do not cross-react with SARS, MERS and other closely related coronaviruses.
These Affimer reagents will be used to develop a point-of-care saliva-based antigen test strip by Cytiva (formerly GE Healthcare Life Sciences) for CE marking in Europe and Food and Drug Administration (FDA) approval in the United States.
The Affimer reagents have now been manufactured by Avacta in the quantities required for test development. The reagents are also being provided to Adeptrix, with whom Avacta has announced that it will develop a COVID-19 laboratory test to run on hospital mass spectrometers using Adeptrix’s proprietary BAMS assay platform.
The Affimer reagents have also now been studied further by Avacta and, importantly, this has shown that there are Affimer reagents that can work in pairs, both binding to the spike protein at the same time. This allows tests to be developed that detect both the intact virus particle and the detached spike proteins which become separated from the virus particle during the development of the COVID-19 disease, which may also be important in monitoring disease progression.
Cytiva and Avacta will now work to develop rapid test strips for the detached spike protein and for the intact virus particle, aiming to have prototype devices in a few weeks. Adeptrix will be working on a similar timescale to develop a prototype BAMS test. Both of these tests will indicate whether a person has the infection at that moment.
Dr Alastair Smith (pictured, Avacta Group CEO) commented: “I am delighted that the COVID-19 antigen test development programme continues ahead of schedule and we are today shipping the Affimer reagents to our partners to begin test development. It is a major accomplishment to have generated Affimer reagents that can work in pairs as well as singly, as this opens up the potential for detecting the detached spike proteins as well as the intact virus particles, which means that we should have the best possible COVID-19 antigen test.
