AXIM® Biotechnologies’ Manufacturing Partner Empowered Diagnostics Files Amended Emergency Use Authorization with FDA for its Rapid COVID-19 Neutralizing Antibody Test in Whole Blood at Point-of-Care Locations
SAN DIEGO, Aug. 30, 2021 – AXIM Biotechnologies (OTCQB: AXIM) announced that its manufacturing partner, Empowered Diagnostics, has filed an amended emergency use authorization (EUA) with the FDA for its COVID-19 neutralizing antibody rapid test, ImmunoPass™. The amendment includes updated clinical trials and studies to validate the test's accuracy. CEO John W. Huemoeller II emphasized the ease of use and fast results of ImmunoPass, aligning with the ongoing demand for COVID-19 antibody testing.
- Amended EUA for ImmunoPass filed with updated clinical trials.
- Test's ease of use and quick results cater to global needs.
- No assurance of FDA approval for ImmunoPass.
- Commercial success of the test remains uncertain.
SAN DIEGO, Aug. 30, 2021 (GLOBE NEWSWIRE) -- 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.
Forward-Looking Statements
The statements made by Axim Biotechnologies Inc., in this press release may be “forward-looking” in nature within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Forward-looking statements describe Axim’s future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Axim Biotechnologies, Inc. Actual results could differ materially from those projected due to there being no assurance that our diagnostic candidate will be successfully shown to detect SARS-CoV-2 neutralizing antibodies, that the diagnostic candidate will be approved for use by the U.S. FDA or any equivalent foreign regulatory agency, that the diagnostic candidate can be manufactured in large quantities or that third parties with an established presence in blood collection clinics, vaccine development, employer or individual use will enter into agreements or purchase from the Company, and even if the Company’s diagnostic candidate is successful, it may generate only limited revenue and profits for the Company, including whether any of Axim’s diagnostic products will receive clearance from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies to sell its products and whether and when, if at all, they will receive final approval from the U.S. FDA or equivalent foreign regulatory agencies, the fact that there has never been a commercial diagnostic test utilizing neutralizing antibodies approved for use and various other factors detailed from time to time in Axim’s SEC reports and filings, including our Annual Report on Form 10-K filed on April 15, 2021 and other reports we file with the SEC, which are available at www.sec.gov. Axim Biotechnologies, Inc., undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, unless otherwise required by law.
CONTACT:
Public Relations Contact:
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www.cmwmedia.com
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Investor Relations Contact:
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