San Diego-based Axim Biotechnologies Inc., an international health care solutions company targeting oncological and COVID-19 research, has filed an emergency use authorization (EUA) application with the U.S. FDA for measuring COVID-19 neutralizing antibodies in plasma and serum through its first-in-class rapid diagnostic test. Axim believes its rapid diagnostic test is expected to be the market’s first COVID-19 rapid diagnostic test for measuring levels of functional neutralizing antibodies in a lateral flow assay format. 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 LLC 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.
