Axim Biotechnology Inc. (OTCMKTS:AXIM) has announced that its manufacturing partner Empowered Diagnostics has filed an Emergency Use Authorization (EUA) application with US FDA for ImmunoPass™’s approval. ImmunoPass™ is the company’s rapid test kit that measures COVID-19 neutralizing antibody levels to detect neutralizing antibodies in whole blood.
AXIM completed clinical trials for ImmunoPass™
Earlier this month, the company announced that the completion of clinical trials indicated that operators found the test kit easy to use in measuring COVID-19 neutralizing antibody levels without any issues. The company partnered with Empowered Diagnostics to put together the results for inclusion in the EUA.
Axim CEO John Huemoeller said that with the recent developments regarding the availability of COVID-19 vaccines to adults by May, travels are likely to resume. Therefore, this makes ImmunoPass™ relevant since neutralizing antibodies decreases at different rates after vaccination. Huemoeller said that to slow COVID-19 spread, there is a need to understand whether a person has received the vaccines and if their neutralizing antibody levels are high enough to guarantee safe travel.
ImmunoPass™ measures functional neutralizing antibodies levels
ImmunoPass is the first-ever coronavirus rapid diagnostic test kit that measures the functional neutralizing antibody levels, which are vital in preventing SARS-CoV-2 from attacking host cells. The company completed point-of-care clinical trials successfully. The test helps understand COVID-19 immunity and the vaccines’ effectiveness to determine how long they can be effective in protecting the body.
Most importantly, AXIM’s ten-minute rapid serological diagnostic test can be used to measure neutralizing antibodies level in people who have received the vaccine or recovered from the virus and offer an “Immunity Passport” so that people can go back to work or travel. Similarly, the test could be vital in screening plasma from individuals who have recovered. Those suffering from COVID-19 can be treated with plasma that contains high functioning neutralizing antibody levels.
Preclinical studies show that ImmunoPass can work with a 97.8% efficacy rate in serum and plasma. Interestingly the test work on all; COVID-19 strains, this the newly identified COVID-19 strains will not affect efficacy.