Duke-NUS, GenScript and A*STAR launch first-in-the-world SARS-CoV-2 serology test to detect neutralising antibodies without need of containment facility or specimen

As a first-in-the-world "rapid smart test kit",A the cPassa??which can measure neutralising antibodies in an hour will be a huge boost to current COVID-19 investigations, from contact tracing, sero-prevalence survey, and assessment of herd immunity, longevity of protective immunity and efficacy of different vaccine candidates.

The global community will be able to use the cPassa??as unlike conventional test kits it does not require live biological materials or biosafety containment for testing.

This test would be instrumental in vaccine and therapeutic development as it is suitable for all antibody isotypes and can be used to determine antibodies in different animal species without any modification.

SINGAPORE, May 20, 2020 /PRNewswire/ -- Duke-NUS Medical School (Duke-NUS), a research intensive graduate-entry medical school, GenScript Biotech Corporation ("GenScript", Stock Code: 1548.HK), a leading global biotechnology company, and the Diagnostics Development Hub (DxD) at Singapore's Agency for Science, Technology and Research (A*STAR), announced an exclusive agreement on 15thMay 2020 to co-develop and manufacture a unique serological coronavirus (COVID-19) detection system known as the surrogate virus neutralisation test (sVNT) or cPassa??. This test is the first in the world that allows rapid detection of neutralising antibodies (NAbs)A -- 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. The cPassa?? test kit has gotten provisional authorization from Singapore Health Sciences Authority (HSA) and CE mark for diagnostic uses. While there are many COVID-19 lab-based antibody test kits commercially available, this is the first that is capable of measuring functional NAbs. 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 cPassa?? 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 the Duke-NUS' Emerging Infectious Diseases programme, and team conceived this research and invented the cPassa??A 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 optimisation, and now plays a central role in the commercialisation process, using its global network and manufacturing capacity to launch cPassa?? in Singapore and other regions around the world. DxD Hub is a national initiative led by A*STAR's commercialisation 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 authorisation 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.
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