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AXIM® Biotechnologies Applies for FDA Emergency Use Approval (EUA) for High Throughput, Patent-Pending Neutralizing Antibody Diagnostic Test for COVID-19
AXIM® Biotechnologies Applies for FDA Emergency Use Approval (EUA) for High Throughput, Patent-Pending Neutralizing Antibody Diagnostic Test for COVID-19.
About this update from Axim Biotechnologies, Inc.
[{"type":"text","content":"\n 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...