Avacta Group and Mologic have entered a partnership to market Avacta’s AffiDX SARS-CoV-2 lateral-flow rapid antigen test. Avacta will also support antigen testing in low- and middle-income countries by providing access to Avacta’s spike antigen test.
The partnership will provide a faster route to market for Avacta’s rapid antigen test by CE-marking it for professional use under Mologic’s existing ISO 13485 quality system. The CE mark will then be transferred to Avacta when it receives ISO 13485 accreditation, which is expected by the end of March 2021.
The partnership also 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. These manufacturing partnerships will deliver several millions of tests per month, and potentially much higher with further investment. Avacta is also continuing its discussions 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.
Dr Alastair Smith (Avacta Group CEO, pictured) commented: “I am very pleased to announce this partnership with Mologic, which follows a close collaboration over recent months. The partnership provides Avacta with a low-risk route to CE marking our rapid antigen test during Q1 ahead of achieving our own ISO 13485 accreditation. I am also delighted that this collaboration provides an opportunity for Avacta to support antigen testing in low- and middle-income countries through Mologic’s international manufacturing links.”
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.