NEW YORK — Avacta has signed an agreement to develop, manufacture, and distribute certain of its SARS-CoV-2 tests in collaboration with British diagnostics firm Mologic, the companies said on Monday.
Under the terms of the deal, Mologic will manage the CE marking of Avacta's AffiDx SARS-CoV-2 lateral flow rapid antigen test under its existing ISO13485 quality system. The CE mark will be transferred to Avacta once it is issued, which is expected to occur before the end of March.
Mologic has also agreed to distribute Avacta's SARS-CoV-2 spike antigen test in undisclosed low- and middle-income countries, as well as to provide Avacta with additional test manufacturing capacity.
UK-based Avacta will also be given access to manufacturing capacity through Mologic and partners including Global Access Diagnostics, which will enable Avacta to make several million tests a month.
The companies said that the alliance could be extended to include future tests, such as a lateral flow device that combines Avacta's spike antigen test and Mologic's nucleocapsid antigen-based technology.
Additional terms of the arrangement were not disclosed.