AXIM® Biotechnologies Signs Exclusive Licensing, Manufacturing and Distribution Agreement for High Volume Production of the COVID-19 Rapid Neutralizing Antibody Test
SAN DIEGO, Aug. 24, 2020 (GLOBE NEWSWIRE) -- (OTCQB: AXIM) (“AXIM® Biotech,” “AXIM” or “the Company”), an international healthcare solutions company targeting oncological and COVID-19 research, announced today that the Company has signed an exclusive limited licensing, manufacturing and distribution agreement with Empowered Diagnostics LLC (“Empowered Diagnostics”) for high volume production of AXIM’s rapid diagnostic test measuring levels of functional neutralizing antibodies that are believed to prevent SARS-CoV-2 from entering the host cells. Empowered Diagnostics will manufacture the lateral flow assay tests under the name Tru-19 Neutralizing Antibody Test (the “Test”).
Empowered Diagnostics, based in Pompano Beach, Florida, is a large volume manufacturer and distributor of cost-effective rapid point-of-care diagnostic solutions. In 2019, Empowered Diagnostics purchased one of the nation’s largest capacity manufacturers of diagnostics tests and is developing propriety innovations to provide the most efficient test production facility in the World.
“Axim’s second-generation tests measures the antibodies that block the disease from getting into our cells, which is a much better way to detect immunity than the current rapid tests in the market,” said Rick Hennessey, CEO of Empowered Diagnostics. “During this time, people need assurance of immunity so they can safely get back to school, work and their daily lives.”
Due to the urgency of the COVID-19 pandemic, Empowered Diagnostics is adding a new automated inline large-scale production capacity, which when installed will be able to manufacture millions of tests per week. Empowered has partnered with a large national sales organization that currently owns labs and sells in-house services and tests to many other independent labs across the country. The sales organization will focus on large employer groups, clinical research companies, health care organizations, professional sports and entertainment venues and academic organizations.
“Our goal in creating our rapid lateral flow assay was to provide as many people as possible with an easy-to-use, accurate and quick tool for measuring their COVID-19 neutralizing antibodies,” AXIM® Biotech CEO John W. Huemoeller II said. “Through this manufacturing agreement with Empowered, we will be able to produce our first-in-class tests right here in the USA in the large volumes necessary to make a difference nationally, while freeing our scientific team’s valuable time for continuing their COVID-19 and oncology research.”
AXIM will receive royalties for all Tests manufactured using the Company’s technology and distributed by Empowered Diagnostics.
In July 2020, AXIM a pre-Emergency Use Authorization Application (EUA) for the test and is finalizing the Company’s EUA submission with Empowered as the manufacturer and distributor. The intellectual property relating to the novel serological test is the subject of Provisional Patent Application No. 63/023,646 “Convalescent Plasma Testing and Treatment” filed on May 12, 2020.
About Empowered Diagnostics Corporation
Empowered Diagnostics, base in Pompano Beach, Florida, is a large volume manufacturer and distributor of cost-effective rapid point-of-care diagnostic solutions. In 2019 Empowered Diagnostics purchased one of the nation’s largest capacity manufacturers of diagnostics tests and developed propriety innovations to provide the most efficient test production facility in the World. Marketed under the TRU brand, Empowered provides the highest quality diagnostics tests to aid in the detection and diagnosis of diseases in order to help improve lives. For more information about Empowered Diagnostics, visit .
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 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 .
FORWARD-LOOKING DISCLAIMER
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 . 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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