AXIM® Biotechnologies Applies for FDA Emergency Use Approval (EUA) for High Throughput, Patent-Pending Neutralizing Antibody Diagnostic Test for COVID-19
SAN DIEGO, Aug. 05, 2020 (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 development, patent filing and Emergency Use Approval (EUA) filing of NeuCovix-HT™, a high throughput (HT) patent-pending diagnostic test that measures levels of functional antibodies in plasma or serum that neutralize SARS-CoV-2, the virus that causes COVID-19. Unlike current serology tests for COVID-19 that qualitatively detect antibodies to the virus, NeuCovix-HT™ quantitatively measures functional antibodies that block binding of the virus to host cell receptors.
As more of the population recovers from COVID-19, NeuCovix-HT™ will benefit clinical laboratories running batches of thousands of tests per week to measure levels of neutralizing antibodies in COVID-19 convalescent plasma. NeuCovix-HT™ distinguishes which convalescent plasmas contain low and high levels of neutralizing antibodies so that patients fighting COVID-19 can be treated with plasma from donors with the highest levels of neutralizing antibodies.
Since AXIM’s NeuCovix-HT™ test correlates closely with virus-based neutralization assays, it is ideal for vaccine manufacturers to measure neutralizing antibody levels in vaccine recipients. NeuCovix-HT™ solves the problem of vaccine manufacturers’ requirement in Phase 3 clinical trials to measure neutralizing antibody levels longitudinally in 30,000 volunteer recipients using expensive and laborious virus-based assays. Clinical centers participating in the vaccine trials could employ NeuCovix-HT™ tests to measure neutralizing antibodies from vaccine recipients in thousands of plasma samples per day.
“In contrast to the commonly used lab tests such as ELISA, our mix-and-read assay technology in addition to being faster, more economical and more sensitive offers much higher sample processing power. We hope this new test format will benefit clinical labs and vaccine development companies that need to process COVID-19 samples in massively parallel and highly accurate fashion,” said Sergei Svarovsky, Ph.D., MBA, Chief Scientific Officer of Sapphire Biotech, a wholly-owned subsidiary of AXIM® Biotech, and co-inventor of NeuCovix-HT™.
AXIM® Biotech CEO John W. Huemoeller II commented: “The development of NeuCovix-HT was leveraged from the same principles of our first lateral flow test. Our high throughput test is highly accurate, reproducible and highly amenable to automation. Our goal is for high-volume clinical laboratories that are performing serological tests on COVID-19 samples to adopt the test because it is important to know if people are making neutralizing antibodies. A second goal is for vaccine companies to adopt this test so they can cost-effectively and accurately monitor every clinical trial participant.”
This news follows recent announcements of AXIM’s filing for a pre-EUA for its rapid 10-minute test measuring a specific subpopulation of antibodies to block binding of the virus to host cell receptors. The test, NeuCovix™, is superior to current time-consuming and expensive tests using live viruses because it is portable, low cost and can be delivered at point-of-care. Initial study results show that the test accurately classified serum from patients who strongly neutralized SARS-CoV-2 and serum from patients who poorly neutralized the virus.
NeuCovix™ and NeuCovix-HT™ have not been approved by the FDA.
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 NeuCovix™ 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 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 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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