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AXIM® Biotechnologies’ Manufacturing Partner Empowered Diagnostics Files for Approval for Use of Rapid COVID-19 Neutralizing Antibody Test in Whole Blood at Point-of-Care Locations in Canada and the EU
AXIM® Biotechnologies’ Manufacturing Partner Empowered Diagnostics Files for Approval for Use of Rapid COVID-19 Neutralizing Antibody Test in Whole Blood at Point-of-Care Locations in Canada and the EU.
About this update from Axim Biotechnologies, Inc.
[{"type":"text","content":"\n SAN DIEGO, May 05, 2021 (GLOBE NEWSWIRE) -- AXIM® Biotechnologies, Inc. (OTCQB: AXIM) (“AXIM® Biotech,” “AXIM” or “the Company”), an international healthcare solutions company targeting oncological and COVID-19 research, announced today that the Company’s manufacturing partner Empowered Diagnostics has filed for emergency approval to use ImmunoPass™, the Company’s rapid test that semi-quantitatively measures levels of COVID-19 neutralizing antibodies, to detect COVID-19 neutralizing antibodies in whole blood at point-of-care locations throughout Canada and the EU. Empowered Diagnostics’ application is currently under review by Health Canada for approval for use in the country. Additionally, the Company has filed for a CE mark, which is required to distribute a product or device on the EU market and signifies that the Company has met the necessary safety, health and environmental protection requirements for sale. Once granted a CE mark, the Company will have approval to manufacture and commercialize ImmunoPass™ for use in point-of-care locations across the EU. Last month, AXIM announced that Empowered Diagnostics filed an Emergency Use Authorization (EUA) application with the US Food and Drug Administration (FDA) for approval to use ImmunoPass™ to detect COVID-19 neutralizing antibodies in whole blood at point-of-care locations. AXIM® Biotech CEO John W. Huemoeller II commented: “The COVID-19 pandemic itself is evidence that the world is interconnected. Because of that, it’s crucial that countries work together to resolve this global issue and have a consistent level of care in order to achieve relative normalcy as quickly as possible. ImmunoPass is incredibly easy to use and delivers accurate results in a matter of minutes, making it an ideal device for global use.” About AXIM® BiotechnologiesFounded in 2014, AXIM® Biotechnologies, Inc. (AXIM) 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 measuring levels of functional neutralizing antibodies that are believed to prevent SARS-CoV-2 from entering the host cells. Additionally, the...