AXIM Biotechnologies unveils rapid test for neutralizing antibodies, files Pre-EUA with the FDA
AXIM Biotechnologies, an healthcare solutions company focused on oncological research, has announced the development of NeuCovix, a rapid diagnostic test measuring levels of functional neutralizing antibodies that are believed to prevent SARS-CoV-2 from entering the host cells, according to a press release from the company.
Unlike currently available serological COVID-19 tests that detect an antibody response to the virus, AXIM’s rapid 10-minute test measures a specific subpopulation of antibodies to block binding of the virus to host cell receptors. 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 (POC) test with results in 10 minutes.
“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 reinfection, and those who do not. 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.
An immediate application of the diagnostic test 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 is to help ensure that vaccines elicit high levels of neutralizing antibodies. When a vaccine is available, manufacturers can employ the test to evaluate protective immune responses in vaccine recipients.
AXIM also announced the filing of a pre-Emergency Use Authorization Application (EUA) and has already initiated dialogue with the FDA in order to finalize its EUA submission.
