On Aug. 24, 2020, AXIM Biotechnologies announced that it had signed an exclusive limited licensing, manufacturing and distribution agreement with Empowered Diagnostics for high volume production of AXIM’s rapid diagnostic test measuring levels of functional neutralizing antibodies that are believed to prevent SARS-CoV-2 from entering the host cells. Empowered Diagnostics will manufacture the lateral flow assay tests under the name Tru-19 Neutralizing Antibody Test.

Empowered Diagnostics, based in Pompano Beach, Florida, is a large volume manufacturer and distributor of cost-effective rapid point-of-care diagnostic solutions. In 2019, Empowered Diagnostics purchased one of the nation’s largest capacity manufacturers of diagnostics tests and is developing propriety innovations to provide the most efficient test production facility in the World.

Due to the urgency of the COVID-19 pandemic, Empowered Diagnostics is adding a new automated inline large-scale production capacity, which when installed will be able to manufacture millions of tests per week. Empowered has partnered with a large national sales organization that currently owns labs and sells in-house services and tests to many other independent labs across the country. The sales organization will focus on large employer groups, clinical research companies, health care organization professional sports and entertainment venues and academic organizations.

AXIM will receive royalties for all Tests manufactured using the Company’s technology and distributed by Empowered Diagnostics. 

In July 2020, AXIM filed a pre-Emergency Use Authorization Application (EUA) for the test and is finalizing the Company’s EUA submission with Empowered as the manufacturer and distributor. The intellectual property relating to the novel serological test is the subject of Provisional Patent Application No. 63/023,646 “Convalescent Plasma Testing and Treatment” filed on May 12, 2020.