SAN DIEGO – December 15, 2020 – 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 it has filed an amended Emergency Use Authorization (EUA) application with the US Food and Drug Administration (FDA).
AXIM first filed the EUA in September for measuring COVID-19 neutralizing antibodies in plasma and serum through its rapid diagnostic test. The Company amended the EUA to include positive results from a Biosafety Level 3 (BSL-3) live virus test that positively correlates the rapid 10-minute lateral flow assay test that accurately detects and measures levels of functional COVID-19 neutralizing antibodies in plasma.
According to a receiver operating characteristic (ROC) curve, AXIM’s ImmunoPass shows 97.8 percent accuracy in detecting neutralizing antibodies. In comparison, Ortho Clinical Diagnostics’ VITROS® Total an IgG COVID-19 Antibody Test, which is FDA authorized and considered the gold standard, shows 85.8 percent accuracy.
AXIM® Biotech CEO John W. Huemoeller II commented: “With this amended EUA, we are one step closer to our goal of providing an ‘Immunity Passport’ through our accurate, fast and relatively inexpensive COVID-19 neutralizing antibody test. Our assay is the only functional test that measures levels of neutralizing antibodies in serum, plasma or whole blood. In addition, it is portable and delivers results in less than 10 minutes. Once approved, it can serve as a reliable option for point-of-care providers and recipients aiming to confirm the durability of vaccine-induced immunity.”
As the world begins administering COVID-19 vaccines, healthcare stakeholders will be able to employ AXIM’s rapid, point-of-care test to evaluate protective immune responses in vaccine recipients to ensure that vaccines elicit high levels of neutralizing antibodies. And as time goes on, AXIM’s test can help monitor vaccine-induced protection to see if future boosters are needed. A second application is to measure levels of neutralizing antibodies in convalescent plasma so that plasma with the highest levels of neutralizing antibodies can be identified and given to patients fighting COVID-19.
In August of this year, AXIM signed an exclusive limited licensing, manufacturing and distribution agreement with Empowered Diagnostics LLC (“Empowered Diagnostics”) for high volume production of the Company’s rapid diagnostic test. Under this agreement, Empowered Diagnostics will manufacture the lateral flow assays under the name “ImmunoPass”. With the filing of this EUA the Company is now able to sell to clinics for use in plasma and/or serum immediately.
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.
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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