AXIM® Biotechnologies, Inc.
(OTCQB: AXIM) (“AXIM® Biotech,” “AXIM” or “the Company”), an
international healthcare solutions company targeting oncological,
COVID-19 and dry eye disease diagnostics, announced today that the
Company’s manufacturing partner Empowered Diagnostics
has filed an amended emergency use authorization (EUA) 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.
AXIM® Biotech CEO John W. Huemoeller II commented, “We have been working diligently with Empowered Diagnostics to make the changes recommended by the FDA as we pursue emergency use authorization for ImmunoPass. As the COVID-19 pandemic continues around the world, people want to understand if they have neutralizing antibodies. 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® Biotechnologies
Founded in 2014, AXIM® Biotechnologies, Inc. (OTCQB: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 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. For more information, please visit www.AXIMBiotech.com.
About Empowered Diagnostics
Empowered
Diagnostics delivers innovative, best-in-class diagnostic tests backed
by leading experts in healthcare and biotechnology. Our mission is to
empower people with the knowledge and confidence to understand their
health through reliable, affordable, high-quality tests. Based in
Pompano Beach, Florida, Empowered Diagnostics is one of the largest
capacity manufacturers of rapid diagnostic solutions in the United
States. For more information, please visit www.empdx.net.
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