Avacta Group plc (AIM: AVCT), the developer of Affimer® biotherapeutics and reagents, is pleased to announce that today it is shipping Affimer reagents for COVID-19 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 COVID-19 antigen test strip by Cytiva (formerly GE Healthcare Life Sciences) for CE marking in Europe and FDA approval in the United States.
The Affimer reagents have now been manufactured by Avacta in the quantities required for test development and are being sent to Cytiva today. 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 BAMSTM 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.
Avacta owns all the intellectual property relating to the SARS-COV-2 Affimer reagents and retains all commercial rights.
Dr Alastair Smith, Chief Executive Officer of Avacta Group, 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.
The need for rapid antigen tests to diagnose COVID-19 infection that can be mass produced for rapid, professional screening of large populations, and for self-testing by consumers themselves, is crucial to limiting and tracking the spread of this disease. Antigen testing will also be critical to lockdown exit strategies around the world in order to get healthy, non-contagious people back to work to re-boot economies, and there will be an ongoing need for several years for antigen testing as the disease recurs.
There has been considerable commercial interest in these reagents since we announced that we had successfully generated them. The Group is very actively exploring further commercial opportunities to develop them with partners into diagnostic tests and with distributors to provide large scale routes to market for professional and home use.
Another important step has been taken in delivering these tests to end users. I look forward very much to updating the market on further progress over the next few weeks.”
THE INFORMATION COMMUNICATED IN THIS ANNOUNCEMENT IS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION 596/2014.