Avacta Expands Rapid SARS-CoV-2 Antigen Test Manufacturing Capacity

Avacta Group plc, the developer of Affimer® biotherapeutics and reagents, is pleased to announce that it has entered into an agreement with Abingdon Health for the manufacture of Avacta’s saliva-based rapid SARS-CoV-2 antigen test as part of its ongoing expansion of manufacturing capacity.

Avacta, in partnership with Cytiva, is developing a rapid test strip for use with patient saliva that aims to provide a result in a few minutes, indicating whether the patient is currently infected with the SARS-CoV-2 coronavirus. The test has the potential to be used for frequent mass testing of the population to promptly identify infectious individuals so that they can be isolated and treated, thereby reducing the spread of infection.

Avacta recently announced a manufacturing partnership with BBI Solutions to develop and validate a scaled-up manufacturing process for the rapid coronavirus antigen test. Avacta, Cytiva and BBI are in the process of technology transfer of the prototype and related manufacturing procedures for the test. Avacta aims to begin clinical validation of the test as soon as possible using the first pilot batches.

Abingdon Health provides innovative rapid testing solutions to a global client base and has Europe’s largest lateral flow test contract manufacturing capacity. Abingdon Health’s two sites in York and Doncaster, UK are able to produce millions of rapid tests per month.

Technology transfer to Abingdon Health will begin immediately with the aim of manufacturing an equivalent rapid antigen test product which therefore does not require additional clinical validation/regulatory approvals. The agreement with Abingdon Health will provide additional manufacturing capacity that could increase to several millions of tests per month.

Authorities around the world are now looking to carry-out frequent mass testing to identify the most infectious people promptly in order to reduce infection rates and combat the coronavirus pandemic. That requires a highly specific test to minimize false positives which would otherwise overwhelm healthcare systems. The Affimer reagents that we have generated are very specific to SARS-CoV-2 antigen and we are confident of meeting and exceeding the clinical performance requirements for identifying the most infectious people.

Manufacturing capacity is therefore the key challenge that has to be met in achieving widespread roll-out of Avacta’s saliva-based rapid antigen test. We therefore continue to actively seek additional manufacturing partners globally to be able to provide the volume of tests that will be required in the UK and elsewhere. I look forward to updating the market on progress in that regard, and will keep the market informed on the key next steps of clinical validation and regulatory approval.”