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AXIM® Biotechnologies Applies for FDA Emergency Use Approval (EUA) for High Throughput, Patent-Pending Neutralizing Antibody Diagnostic Test for COVID-19SAN 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 FORWARD-LOOKING DISCLAIMER CONTACT: AXIM Corporate Contact Info: Investor Relations Contact: |