AXIM Biotechnologies applied for FDA Emergency Use Approval for high throughput, neutralizing antibody diagnostic test for COVID-19

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On Aug. 5, 2020, AXIM Biotechnologies announced the development, patent filing and Emergency Use Approval (EUA) filing of NeuCovix-HTTM, 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 serology tests for COVID-19 that qualitatively detect antibodies to the virus, NeuCovix-HTTM quantitatively measures functional antibodies that block binding of the virus to host cell receptors.

As more of the population recovers from COVID-19, NeuCovix-HTTM will benefit clinical laboratories running batches of thousands of tests per week to measure levels of neutralizing antibodies in COVID-19 convalescent plasma. NeuCovix-HTTM 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-HTTM test correlates closely with virus-based neutralization assays, it is ideal for vaccine manufacturers to measure neutralizing antibody levels in vaccine recipients. NeuCovix-HTTM 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-HTTM tests to measure neutralizing antibodies from vaccine recipients in thousands of plasma samples per day.

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Source: AXIM Biotechnologies
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