Duke-NUS Medical School, a research intensive graduate-entry medical school, along with the biotech GenScript and the Diagnostics Development Hub (DxD) at Singapore’s Agency for Science, Technology and Research (A*STAR), have entered an agreement to co-develop and manufacture a serological coronavirus (COVID-19) detection system known as the surrogate virus neutralization test (sVNT) or cPass. This test is the first in the world that allows rapid detection of neutralizing antibodies (NAbs)—the specific antibodies present in the serum of COVID-19 patients that are responsible for clearing the viral infection, without the need of live biological materials and biocontainment facility.
 
While there are many COVID-19 lab-based antibody test kits commercially available, this is the first that is capable of measuring functional Nabs, according to the company. Without a simple test kit, measuring NAbs requires the use of live virus, cells, highly skilled operators, and complex laboratory procedures that are generally less sensitive and require several days to obtain results. By contrast, the cPass can be rapidly conducted within an hour in most research or clinical labs, and is also amenable to high throughput and fully automated testing after minimal adaptation. This test will also help in current COVID-19 investigations, from contact tracing to determining infection rates, herd immunity and predicted humoral protection.
 
Professor Wang Linfa, director of Duke-NUS’ Emerging Infectious Diseases program, and team conceived this research and invented the cPass diagnostic test. The team also did the assay development and testing in Singapore.
 
GenScript went through the steps of proof concept research, product design, development and optimization, and now plays a central role in the commercialization process, using its global network and manufacturing capacity to launch cPass in Singapore and other regions around the world.
 
DxD Hub is a national initiative led by A*STAR’s commercialization arm, A*ccelerate. To take this sVNT to market, DxD Hub validated the kit with clinical samples, and developed the manufacturing protocol and quality controls to secure its provisional authorization by the Health Sciences Authority. DxD Hub will also be producing the pilot batch for use in Singapore hospitals. There are plans for this know-how to be transferred to local biotech companies for scaled-up production.
 
“The cPass developed by our team can be used for contact tracing, reservoir or intermediate animal tracking, assessment of herd immunity, longevity of protective immunity and efficacy of different vaccine candidates. It does not require a biosafety containment facility, which makes it immediately accessible to the global community, including many developing nations,” said Prof. Linfa, the principal investigator of this collaboration. One of the most internationally recognized experts on emerging zoonotic viruses, he currently serves on multiple World Health Organization committees focusing on COVID-19.
 
“Duke-NUS is excited to partner with GenScript as well as DxD Hub to address the challenge of COVID-19 serology with this novel detection system. This could be a game changer in the field of COVID-19 investigation,” said Professor Patrick Casey, senior vice dean of research at Duke-NUS.
 
Zhu Li, chief strategy officer, GenScript added, “The serological detection system developed by Prof Wang is unique, innovative, and has many advantages, such as high sensitivity and specificity, and applicability to all antibody isotypes. The test results will be of great help to governments in guiding the resumption of work since it is extremely useful for quick and reliable surveillance to determine how widely a population has gained immunity to SARS-CoV-2 virus. Detection of neutralising antibodies determines who can more safely go back to work or to more social life.  Our partnership with Duke-NUS and DxD Hub is one of several proactive steps we are taking to strengthen our R&D and manufacturing capacity to meet this urgent global need.”