On Sept. 16, 2020, AXIM Biotechnologies announced that it had filed an Emergency Use Authorization (EUA) application with the FDA for measuring COVID-19 neutralizing antibodies in plasma and serum through its first-in-class rapid diagnostic test.

Neutralizing antibodies prevent SARS-CoV-2, the virus responsible for the current COVID-19 pandemic, from binding to and entering host cells.

Last month, AXIM signed an exclusive limited licensing, manufacturing and distribution agreement with Empowered Diagnostics for high volume production of the Company’s rapid diagnostic test. Under this agreement, Empowered Diagnostics will manufacture the lateral flow assays under the name “Tru-19 Neutralizing Antibody Test” (“Tru-19”). With the filing of this EUA, the Company is now able to begin selling Tru-19 to clinics immediately. 

Tru-19 is unlike other rapid serological COVID-19 tests currently on the market because it measures levels of neutralizing antibodies in serum or plasma from patients that have recovered from COVID-19. With this knowledge, plasma with the highest levels of neutralizing antibodies can be identified and administered to patients fighting COVID-19. Since the Tru-19 test agrees with virus-based assays, it could be a tool for monitoring levels of neutralizing antibodies in large numbers of vaccine recipients. 

Tru-19 can also be used to measure levels of neutralizing antibodies in patients receiving hyperimmune globulin or convalescent plasma so that healthcare providers can decide on the proper dosing of neutralizing antibodies that correlates with favorable outcomes. In the future, AXIM intends to make Tru-19 available to large employer groups, essential workers, and others who would like to know their levels of protective neutralizing antibodies.