SAN DIEGO – September 16, 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 it has filed an Emergency Use Authorization (EUA) application with the Food and Drug Administration (FDA) for measuring COVID-19 neutralizing antibodies in plasma and serum through its first-in-class rapid diagnostic test.
AXIM’s rapid diagnostic test is expected to be the market’s first COVID-19 rapid diagnostic test for measuring levels of functional neutralizing antibodies in a lateral flow assay format. Neutralizing antibodies prevent SARS-CoV-2, the virus responsible for the current COVID-19 pandemic, from binding to and entering host cells.
Last month, 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 “Tru-19 Neutralizing Antibody Test” (“Tru-19”). With the filing of this EUA, the Company is now able to begin selling Tru-19 to clinics immediately.
Tru-19 is unlike other rapid serological COVID-19 tests currently on the market because it measures levels of neutralizing antibodies in serum or plasma from patients that have recovered from COVID-19. With this knowledge, plasma with the highest levels of neutralizing antibodies can be identified and administered to patients fighting COVID-19. Since the Tru-19 test agrees with virus-based assays, it could be a tool for monitoring levels of neutralizing antibodies in large numbers of vaccine recipients.
Tru-19 can also be used to measure levels of neutralizing antibodies in patients receiving hyperimmune globulin or convalescent plasma so that healthcare providers can decide on the proper dosing of neutralizing antibodies that correlates with favorable outcomes. In the future, AXIM intends to make Tru-19 available to large employer groups, essential workers, and others who would like to know their levels of protective neutralizing antibodies.
AXIM® Biotech CEO John W. Huemoeller II commented: “Our ultimate goal is to get Tru-19 approved and manufactured as a point-of-care test as quickly possible. We are confident that once care providers see how easy to use Tru-19 is, it will become the go-to choice for assessing levels of immunity and protection against re-infection. All roads point to neutralizing antibodies as a key measurement in defeating COVID-19.”
Earlier this year, AXIM announced that Tru-19 accurately classified serum from patients who strongly neutralized SARS-CoV-2 and serum from patients who poorly neutralized the virus. Importantly, Tru-19 did not cross-react with serum from patients with seasonal respiratory infections including seasonal coronaviruses, suggesting that the test is highly specific for COVID-19.
About AXIM® Biotechnologies
Founded in 2014, AXIM® Biotechnologies, Inc. (AXIM) is a vertically integrated oncology company developing rapid diagnostic tests for the early detection of cancer and proprietary small molecules drugs to treat cancer and block metastasis. The Company is also developing novel antibodies for therapeutic and diagnostic uses for oncological therapeutics. 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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