First-in-Class COVID-19 Rapid Diagnostic Test for Neutralizing Antibodies Could Serve as Immunity Passport for Vaccine Developers

A new rapid diagnostic test for measuring levels of functional neutralizing antibodies that are believed to prevent SARS-CoV-2 from entering the host cells could serve as an ‘Immunity Passport’ for vaccine developers around the world as they begin larger Phase II and III clinical trials.

NeuCovix, a rapid 10-minute test unveiled by AXIM Biotechnologies, Inc. (San Diego, CA, USA), measures a specific subpopulation of antibodies to block binding of the virus to host cell receptors, unlike the currently available serological COVID-19 tests that detect an antibody response to the virus. While there are expensive, time consuming laboratory tests that measure neutralizing antibodies, NeuCovix differs in that it is a portable, low cost, rapid point-of-care test with results in 10 minutes.

An immediate application of NeuCovix is to measure levels of neutralizing antibodies in convalescent plasma so that plasma with the highest levels of neutralizing antibodies can be identified and administered to patients fighting COVID-19. Without this knowledge, many patients could be undertreated with non-neutralizing plasma and may not benefit from this treatment. Another application of NeuCovix is to help ensure that vaccines elicit high levels of neutralizing antibodies. When a vaccine is available, manufacturers can employ the NeuCovix rapid, point-of-care test to evaluate protective immune responses in vaccine recipients.

“We are hopeful our test fills an important need in these uncertain times. While other tests merely show whether someone was infected with coronavirus, we took it a step further by creating a test that stratifies individuals into those who have neutralizing antibodies, which are essential in preventing re-infection, and those who don’t. The test can be deployed for point of care use in convalescent plasma transfusions to severely ill patients and for evaluating efficacy of upcoming vaccines in generating protective antibodies,” said Sergei Svarovsky, PhD, MBA, AXIM’s CSO and co-inventor of NeuCovix.

“Our goal was to make this test, accurate, fast and relatively inexpensive so it could serve as an ‘Immunity Passport’ for vaccine developers around the world as they begin larger Phase II and III clinical trials. We are optimistic that NeuCovix will be widely used, becoming the gold standard in assessing levels of immunity,” said AXIM Biotech CEO John W. Huemoeller II.

“Everybody who recovers from COVID-19 makes antibodies against the virus, but since all antibodies are not created equal, you really want to know if the antibodies you make neutralize the virus. People who recover want to make sure they are protected from re-infection and that they won’t infect others,” said Doug Lake, Ph.D. and co-inventor of NeuCovix.

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AXIM Biotechnologies, Inc.