AXIM Biotechnologies Applauds FDA's Recent COVID-19 Test Policies to Support Rapid Neutralizing Antibody Tests

Rhea-AI Summary

AXIM Biotechnologies is currently under FDA review for its first rapid test to measure neutralizing antibodies for COVID-19. The FDA has prioritized emergency use authorization for various diagnostic tests, enhancing the company's testing efforts. AXIM has developed three types of neutralizing antibody tests, demonstrating over 90% sensitivity and 100% specificity in trials. The manufacturing partner has filed for Emergency Use Authorization in Canada and the EU. This advancement aligns with AXIM’s strategy to improve COVID-19 diagnostics significantly.

Positive

• AXIM's neutralizing antibody test is under FDA review, which could enhance market presence.
• The company has developed three effective types of neutralizing antibody tests.
• The test shows over 90% sensitivity and 100% specificity according to benchmarks.

Negative

• There is no guarantee that the diagnostic candidate will receive FDA approval.
• Potential challenges in large-scale manufacturing of the diagnostic tests.
• Uncertainty regarding revenue generation even if the tests are successful.

Company’s first rapid test to measure neutralizing antibodies is currently under FDA review

SAN DIEGO, Nov. 18, 2021 (GLOBE NEWSWIRE) -- AXIM Biotechnologies, Inc. (OTCQB: AXIM) (“AXIM® Biotech,” or “the Company”), an international healthcare solutions company targeting oncological, COVID-19 and Dry Eye Disease (DED) diagnostics, today applauds the FDA on its recent update to its COVID-19 test policies that aims to increase nationwide access to at-home and point-of-care tests as well as ensure the accuracy and reliability of such diagnostic tests.

As part of the agency’s mission to support increased access to at-home and point-of-care COVID-19 testing efforts, the FDA has announced its focus on emergency use authorization (EUA) requests for various diagnostic tests for use with or without a prescription that can be manufactured in high volumes. This includes lab-based and point-of-care high-volume antibody tests that can measure the amount of antibodies (fully quantitative antibody tests) or the amount of neutralizing antibodies. This further supports AXIM’s development of its Rapid Neutralizing Antibody Test for COVID-19.

“For the first time ever, the agency is publicly prioritizing the review and approval of neutralizing antibody tests,” said John W. Huemoeller II, AXIM® Biotech Chief Executive Officer. “Only a specific subset of antibodies are able to neutralize the COVID-19 virus. Measuring the levels of neutralizing antibodies determines if a person has the specific antibodies that deactivate the virus and are associated with adaptive immune response. This is excellent news for AXIM as we made it a priority early on in the pandemic to develop a test to measure neutralizing antibody levels.”

Currently, AXIM has developed three different types of neutralizing antibody tests including:

• A qualitative test that measures levels of neutralizing antibodies using a reader;
• A semi-quantitative test that provides three measures of neutralizing antibody levels -- low, medium and high;
• And a qualitative test that provides yes/no results indicating whether the number of neutralizing antibodies is likely to provide immunity from contracting the virus have been detected.
  

AXIM recently announced the publication of an article on the development of its test in the Journal of Clinical Virology, which was conducted by Dr. Douglas Lake, an associate professor at Arizona State University. The article outlined how the test can be performed in a point-of-care setting or by an individual and has demonstrated over 90% sensitivity and 100% specificity when benchmarked against an authentic SARS-CoV-2 neutralization assay using serum samples from COVID-19 patients. Additionally, AXIM’s manufacturing partner Empowered Diagnostics has filed for Emergency Use Authorization for the point-of-care qualitative test, which is pending final review and approval in Canada and the EU.

About AXIM® Biotechnologies
Founded in 2014, AXIM® Biotechnologies, Inc. (AXIM) is a vertically integrated research and development company focused on changing the landscape of diagnosis of SARS-CoV-2 (COVID-19), dry eye disease (DED) and Oncological indications. AXIM’s COVID-19 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 ophthalmological conditions such as DED. 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 April 15, 2021 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
Kathryn Brown
Account Director
CMW Media
P. 858-264-6600
kathryn@cmwmedia.com 
www.cmwmedia.com

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

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

FAQ

What is the status of AXIM Biotechnologies' antibody test?

AXIM Biotechnologies is under FDA review for its first rapid test to measure neutralizing antibodies for COVID-19.

What types of tests has AXIM developed?

AXIM has developed three types of neutralizing antibody tests: qualitative, semi-quantitative, and another qualitative test indicating immunity.

What are the sensitivity and specificity results of AXIM's test?

AXIM's test has demonstrated over 90% sensitivity and 100% specificity when benchmarked against an authentic SARS-CoV-2 neutralization assay.

Has AXIM Biotechnologies filed for Emergency Use Authorization?

Yes, AXIM's manufacturing partner has filed for Emergency Use Authorization for the point-of-care qualitative test, currently pending in Canada and the EU.