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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.
[[nid:508067]]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.
