AXIM® Biotechnologies Begins Clinical Trials on Its ImmunoPass Rapid Diagnostic Test With Vaccine Recipients
AXIM Biotechnologies, Inc. has announced the initiation of clinical trials for its rapid point-of-care test, ImmunoPass, designed to measure neutralizing antibodies to COVID-19. As vaccinations progress, monitoring immunity has become crucial to assess vaccine efficacy and timing for booster shots. Unlike existing tests, ImmunoPass focuses on functional neutralizing antibodies, potentially serving as a low-cost alternative for large-scale monitoring. The company's efforts solidify its position in the COVID-19 diagnostic landscape, though market success depends on regulatory approval and demand dynamics.
- Initiation of clinical trials for ImmunoPass, indicating progress in COVID-19 diagnostics.
- ImmunoPass focuses on functional neutralizing antibodies, potentially offering better accuracy than existing tests.
- Could serve as a low-cost alternative for large-scale monitoring of vaccine recipients.
- No assurance that ImmunoPass will be successfully shown to detect neutralizing antibodies.
- Regulatory approval from the U.S. FDA or equivalent foreign bodies remains uncertain.
- Limited revenue generation potential even if products receive approval.
SAN DIEGO, Feb. 03, 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 the initiation of clinical trials for ImmunoPass, the Company’s rapid point-of-care test that semi-quantitatively measures levels of neutralizing antibodies to COVID-19.
As a variety of COVID-19 vaccines begin rolling out to the general public, immunity monitoring is starting to play a critical role in determining whether the vaccine is effective, for how long, and when it is time to get a booster shot. Since immunity to the virus is not anticipated to last forever, the immunity monitoring could continue for many years even after widespread vaccination throughout the world.
Measuring neutralizing antibodies in people after vaccination may give a better look at how vaccine responses hold up over time. That way, when levels of neutralizing antibodies eventually dip, researchers will have a sense of when they're unacceptably low and a revaccination is needed.
The most widely used antibody tests on the market today do not specifically identify neutralizing antibodies. Instead, they measure a large family of antibodies that bind to various parts of the virus, but not necessarily neutralize it. To address this shortcoming, AXIM® Biotech developed a patent-pending rapid diagnostic test called ImmunoPass, which is specifically focused on measuring the levels of functional neutralizing antibodies that prevent SARS-CoV-2 from attaching to human cells. The test is based on blocking the interaction between human cell receptors and the viral spike protein that mimics the virus neutralization process in the body.
AXIM’s ImmunoPass has shown a significantly better statistical correlation with SARS-CoV-2 neutralization assays than the currently available antibody tests. Since the rapid test agrees well with live virus-based assays, it could serve as an effective low-cost alternative to lab-based assays for monitoring large numbers of vaccine recipients for neutralizing antibodies.
Although clinical trials indicated that COVID-19 vaccines may be remarkably successful, even 95 percent effectiveness will leave millions of Americans unprotected. Neutralizing antibody testing may help determine efficacy and should help indicate whether a person is protected against the virus.
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.
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FAQ
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