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, Inc. (OTCQB: AXIM) announced that its manufacturing partner, Empowered Diagnostics, has applied for emergency approval of ImmunoPass™, a rapid test for measuring COVID-19 neutralizing antibodies. The application is under review by Health Canada, and a CE mark application has also been filed for the EU. Previously, Empowered Diagnostics sought Emergency Use Authorization from the U.S. FDA. CEO John W. Huemoeller II emphasized the importance of rapid testing in managing the pandemic and achieving a return to normalcy.
- Empowered Diagnostics filed for emergency approval in Canada and CE mark for EU distribution of ImmunoPass™.
- ImmunoPass™ is a rapid test that provides accurate COVID-19 neutralizing antibody results in minutes.
- Potential risks include the uncertainty of regulatory approvals from Health Canada and the U.S. FDA.
- No assurance that the diagnostic candidate will be successful in detecting antibodies or achieving large-scale manufacturing.
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® Biotechnologies
Founded 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 Company is developing rapid diagnostic tests for the early detection of cancer and proprietary small molecules drugs to treat cancer and block metastasis. 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 May 13, 2020 and our subsequent quarterly report on Form 10-Q filed on June 30, 2020, 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.
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FAQ
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