Avacta Group has announced a commercial partnership with Mologic for the AffiDX SARS-CoV-2 lateral flow rapid antigen test.
Under the deal, the companies will focus on accelerating the marketing efforts of Avacta’s SARS-CoV-2 lateral flow rapid antigen test.
The partnership is expected provide Avacta’s SARS-CoV-2 rapid antigen test a CE marking for professional use under Mologic’s existing ISO13485 quality system.
Later, the CE mark will be transferred to Avacta upon it securing ISO13485 accreditation that is expected by the end of March this year.
The lateral flow test’s clinical assessment is currently being conducted at a hospital in mainland Europe. The company will also begin further clinical validation studies in the UK and overseas.
The partnership will also allow both companies to enter into a framework agreement for the future development of a pipeline of tests in various disease areas.
Both firms are also evaluating options of combining Avacta’s spike antigen test with Mologic’s nucleocapsid antigen-based technology in a single lateral flow device. The combination is expected to hold potential for an extremely sensitive lateral flow coronavirus antigen test.
Through Mologic, Avacta will also offer its spike antigen test in low and middle-income countries to improve the access to Covid-19 testing.
Avacta is also currently negotiating with other manufacturers in the UK and other countries to access additional capacity to meet demand.
The collaboration also allows to offer Avacta with additional manufacturing capacity via Mologic and its partners including Global Access Diagnostics (GAD), in addition to scaling of manufacturing capacity being developed with BBI and Abingdon Health.
Avacta Group CEO Dr Alastair Smith said: “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 ISO13485 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.”
In September 2020, Avacta announced the introduction of SARS-CoV-2 enzyme linked immunosorbent assay (ELISA) laboratory test.
