AXIM® Biotechnologies Successfully Completes Point-of-Care Clinical Trials on its Rapid COVID-19 Neutralizing Antibody Test

Rhea-AI Summary

AXIM Biotechnologies has completed successful point-of-care clinical trials for its ImmunoPass rapid test, which measures COVID-19 neutralizing antibodies. Conducted in collaboration with Empowered Diagnostics and a university medical center, the trials confirmed ease of use and accuracy in determining immunity levels. The Company plans to file an Emergency Use Application with the FDA for the test's approval. AXIM is also finalizing additional studies to further validate ImmunoPass’s accuracy under varying conditions.

Positive

• Successful completion of ImmunoPass clinical trials.
• Tests confirm that ImmunoPass is easy to use and accurate.
• Plans to file an Emergency Use Application with the FDA soon.

Negative

• None.

SAN DIEGO, March 08, 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 it has successfully completed point-of-care clinical trials on its much awaited ImmunoPass rapid test that semi-quantitatively measures levels of COVID-19 neutralizing antibodies to help understand COVID-19 immunity, validate vaccine’s effectiveness and estimate how long the vaccine will be effective in patients.

The Company conducted two studies, one in partnership with the Company’s manufacturing partner Empowered Diagnostics and the second in partnership with a top accredited university medical center. The main goal of these studies was to identify the ability of operators to successfully utilize ImmunoPass to accurately measure each participant’s level of neutralizing antibodies. Study findings reveal that operators found ImmunoPass easy to use and that they encountered no issues in using the Company’s test to measure participants’ COVID-19 neutralizing antibodies.

AXIM® Biotech CEO John W. Huemoeller II commented: “We want to thank those who volunteered for the studies as they would not have been possible without their participation. These studies are a critical step in our goal of getting ImmunoPass to point-of-care locations as quickly as possible to aid in slowing the spread of the COVID-19 virus. Our study results demonstrate that ImmunoPass is easy to operate in addition to being affordable, portable, quick and accurate.”

The Company is currently working with Empowered Diagnostics to compile the study results and file an Emergency Use Application (EUA) with the U.S. Food and Drug Administration (FDA) for the use of ImmunoPass in detecting COVID-19 neutralizing antibodies in whole blood at point-of care locations.

AXIM and Empowered Diagnostics are finalizing a robustness study on ImmunoPass to further confirm the test’s accuracy when conducted under varying conditions. To date, the Company has completed various interference studies and live virus studies in this process.

To learn more about ImmunoPass, please visit https://aximbiotech.com/science/covid-19-diagnostic-research/.

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.

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.

CONTACT:
Public Relations Contact:
Kathryn Brown
Account Supervisor
CMW Media
P. 858-264-6600
kathryn@cmwmedia.com
www.cmwmedia.com

AXIM Corporate Contact Info:
6191 Cornerstone Ct., Ste. 114
San Diego, CA 92121, USA
P. 858-923-4422

Investor Relations Contact:
investors@aximbiotech.com 
888-759-0844

FAQ

What is ImmunoPass from AXIM?

ImmunoPass is a rapid test developed by AXIM Biotechnologies that semi-quantitatively measures levels of COVID-19 neutralizing antibodies.

What were the results of the ImmunoPass clinical trials?

The trials demonstrated that operators found ImmunoPass easy to use and accurate in measuring COVID-19 neutralizing antibodies.

When will AXIM file for FDA approval for ImmunoPass?

AXIM is currently compiling study results to file an Emergency Use Application with the FDA.

What future studies are planned for ImmunoPass?

AXIM is finalizing a robustness study to confirm ImmunoPass's accuracy under various conditions.

How does ImmunoPass impact COVID-19 testing?

ImmunoPass aims to provide rapid assessment of COVID-19 immunity, helping to validate vaccine effectiveness and duration.