On Aug. 30, 2021, AXIM Biotechnologies announced that the Company’s manufacturing partner Empowered Diagnostics had filed an amended emergency use authorization with the Food and Drug Administration (FDA) for ImmunoPass, the Company’s rapid test that detects COVID-19 neutralizing antibodies at point-of-care locations.

After several discussions with the FDA, the Company amended the EUA application for the test results to be interpreted as qualitative. The package submitted also included updated clinical trials, BSL3 lab live virus comparisons, stability and control studies and a robustness study on ImmunoPass to further validate the test’s accuracy when conducted under varying conditions.

Founded in 2014, AXIM® Biotechnologies is a vertically integrated research and development company focused on changing diagnosis and treatment for oncology and SARS-CoV-2 (COVID-19). AXIM’s COVID-19 rapid neutralizing antibody test is the first rapid diagnostic test functional neutralizing antibodies that are believed to prevent SARS-CoV-2 from entering the host cells. The Company is developing rapid diagnostic tests for the early detection of cancer and proprietary small molecules drugs to treat cancer and block metastasis. Additionally, the Company has signed a Binding Term Sheet to acquire the technology for the testing of Dry Eye Disease (DED), a condition that affects 344 million people worldwide.