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SINGAPORE – A kit that detects whether someone has antibodies that neutralize the coronavirus, invented by local researchers, has become the first of its kind to receive clearance from the US Food and Drug Administration (FDA).
On Friday (November 6), the FDA said on its website that it had granted an emergency use authorization for the kit, known as cPass.
cPass was invented by a team led by Professor Wang Linfa, director of the Duke-NUS Emerging Infectious Diseases Program, and jointly developed with biotech company GenScript Biotech Corporation and the Agency for Science’s Diagnostic Development Center technology and research (A * Star) (DxD Hub).
It can be used to see if vaccines are working, check what proportion of the population has already been infected, and help track contacts by allowing health authorities to track the virus.
cPass also does not require highly specialized equipment or training to use, and returns results in just one hour.
On Sunday, Professor Wang told The Straits Times that FDA approval was extremely important not only for his team, but also for Singapore.
He said: “To have FDA approval as the world’s first and only commercial Sars-CoV-2 neutralizing antibody kit is a very high bar to reach. This is incredible recognition for our team and research from Singapore and the biotech landscape.
“Singapore’s total critical mass for biomedical R&D is less than 1 percent of that (global) and yet we are the international leader in this area for Covid-19.”
The FDA said it had previously issued an emergency use authorization for about 50 serological tests, which also detect antibodies.
But he added that these kits only detect the presence of binding antibodies, which bind to a virus but do not necessarily decrease its ability to infect and destroy cells.
On the other hand, neutralizing antibodies, which cPass detects, are believed to prevent the coronavirus from infecting a patient’s cells.
Professor Wang acknowledged, as he had done on previous occasions, that just because someone has such antibodies does not mean that they are immune to Covid-19.
But “there is consensus that neutralizing antibodies definitely play an important role in providing immunity … they are the only biomarker of immunity that we can measure practically on a large scale,” he said.
Dr. Timothy Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health, said the ability to detect such antibodies can help researchers better understand their impact on patients. .
He said: “There are still many unknowns about what the presence of Sars-CoV-2 antibodies can tell us about potential immunity, but today’s authorization gives us another tool to evaluate those antibodies as we continue to research and study this virus.”
Professor Wang said that after FDA clearance, Duke-NUS, DxD and GenScript will work to expand the application and geographic scope of the kits.
He added that cPass will also play an important role in the search for the origin of the coronavirus, since it can detect neutralizing antibodies not only in humans, but also in any species of animal.
He said his team has already got two grants from the World Health Organization to work on this.
DxD CEO Dr. Sidney Yee said that DxD is currently working with labs here to implement the kits locally.
The Straits Times has approached the Ministry of Health for information on this deployment.
Professor Wang said: “Considering that we expect many vaccines to be massively deployed in the next three to six months, mass testing of cPass will be an integral part of the ‘exit strategy’ for Singapore and all nations of the world.”
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