By working together over the next few months they aim to accelerate to market Avacta’s AffiDX™ SARS-CoV-2 lateral flow rapid antigen test. They will CE mark it for professional use under Mologic’s existing ISO13485 quality system.
The CE mark will then be transferred to Avacta when it receives ISO13485 accreditation, which is expected by the end of March.
The alliance also immediately provides Avacta with additional manufacturing capacity through Mologic and its partners including Global Access Diagnostics (GAD), in addition to the scaled-up manufacturing capacity being built with BBI and Abingdon Health.
Combined, these manufacturing partnerships will deliver several millions of tests per month, and potentially much higher with further investment. Avacta is also continuing talks with other manufacturers in the UK and overseas in order to access additional capacity to meet demand.
Clinical evaluation of the lateral flow test is currently being carried out at a hospital in mainland Europe and Avacta will shortly initiate further clinical validation studies in the UK and abroad.
The partnership between Avacta and Mologic also provides a framework agreement for the future development of a pipeline of tests in a range of disease areas.
The possibility of combining Avacta’s spike antigen test with Mologic’s nucleocapsid antigen-based technology in a single lateral flow device is already being explored.
A hybrid antigen test such as this is expected to be a world first and has the potential to deliver an extremely sensitive lateral flow coronavirus antigen test.