SINGAPORE – A kit that detects if someone has antibodies to coronavirus, invented through local researchers, is the first of its kind to obtain U. S. Food and Drug Administration (FDA) approval.
On Friday, November 6, the FDA said it had granted an emergency use authorization for the kit, known as cPass.
cPass invented through a team led by Professor Wang Linfa, director of Duke-NUS’ Emerging Infectious Diseases Program, and developed in conjunction with biotechnology company GenScript Biotech Corporation and the Diagnostic Development Center of the Science, Technology and Research (A-Star) Agency (DxD Hub).
It can be used to see if vaccines are working, check what proportion of the population has already been infected, and locate contacts by allowing the fitness government to indicate the stages of the virus.
cPass also requires highly specialized devices or education and returns effects in just one hour.
On Sunday, Professor Wang told the Straits Times that FDA approval is incredibly vital not only for his team, but also for Singapore.
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He said: “Getting FDA approval as the first and only advertising kit to neutralize antibodies for Sars-CoV-2 in the world is a very high bar to reach. This is an incredible popularity for our Singapore team and studios and the biotechnological landscape.
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The FDA said it had issued an emergency use authorization in the past for about 50 serological tests, which also detect antibodies.
But he added that these kits only come with the presence of binding antibodies, which join a virus but necessarily diminish their ability to infect and destroy cells.
On the other hand, neutralizing antibodies, detected through cPass, would prevent the coronavirus from infecting a patient’s cells.
Professor Wang stated, as he had already done, that the fact that a user has such antibodies means that he is immune to Covid-19.
But “it is accepted that neutralizing antibodies play a vital role in granting immunityArray. They’re the only immunity biomarker we can almost measure on a giant scale,” he said.
Dr. Timothy Stenzel, director of the Office of In vitro Diagnostics and Radiological Health at the FDA’s Center for Radiological Devices and Health, said the ability to stumble upon such antibodies can help researchers better perceive their effect on patients.
He said: “There are still many unknowns about what the presence of Sars-CoV-2 antibodies can tell us about prospective immunity, however today’s authorization gives us a tool to compare those antibodies as we continue with studies and examination of this virus. “
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Professor Wang said that after FDA approval, Duke-NUS, DxD and GenScript will work to expand the application and geographic success of the kits.
He added that cPass will also play a role in finding the origin of the coronavirus because it may stumble upon neutralizing antibodies not only in humans, but also in all animal species.
He said he had already won two grants from the World Health Organization to paint on the subject.
DxD manager Dr. Sidney Yee said DxD is lately working with labs here to deploy the kits locally.
The Straits Times contacted the Department of Health to learn about the deployment.
Professor Wang said: “As we expect many vaccines to be deployed en masse in the next 3-6 months, cPass Mass will be an integral component of the ‘exit strategy’ for Singapore and all nations of the world. “
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This article was first published in The Straits Times. Permission is required for reproduction.