First-in-the-world SARS-CoV-2 Serology Test to Detect Neutralising Antibodies
cPass can measure antibodies in an hour which is a huge boost to current COVID-19 investigations
Singapore: GenScript Biotech Corporation, a global biotechnology company said that it is partnering with Duke-NUS Medical School, and the Diagnostics Development Hub (DxD) at Singapore’s Agency for Science, Technology and Research (A*STAR), to co-develop and manufacture a unique serological coronavirus (COVID-19) detection system. The kit known as the surrogate virus neutralisation test (sVNT) or cPass can quickly detect neutralising antibodies (NAbs). The test can pick up specific antibodies present in the serum of COVID-19 patients that are responsible for clearing the viral infection identifying the disease and immune response.
“This innovative platform developed by our researchers will be extremely useful for quick and reliable surveillance to determine how widely a population has gained immunity to SARS-CoV-2 virus. The partnership with GenScript and DxD Hub combines complementary strengths as we work together to fight this global outbreak,” said Professor Thomas M. Coffman, Dean of Duke-NUS.
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 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 programme, 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 optimisation, and now plays a central role in the commercialisation process, using its global network and manufacturing capacity to launch cPass in Singapore and other regions around the world.
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.
“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 Professor Wang Linfa, the principal investigator of this collaboration. One of the most internationally recognised experts on emerging zoonotic viruses, he currently serves on multiple World Health Organisation committees focusing on COVID-19.
Dr Zhu Li, Chief Strategy Officer of 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.”
“Recently, GenScript has started to serve Singapore market by utilising our internal sales organisation along with other commercial functions for market access, marketing and distribution. We are excited to be part of the thriving culture of innovation across laboratories in the Asia Pacific Region. Our partnership aims to make the best use of our mutual capabilities, expertise, and resources, which helps us to serve our community better,” said Johnson Wang, President in Asia Pacific Region at GenScript.
The cPass assay was validated with samples of patients from PROTECT- A Multi-centred Prospective Study to Detect Novel Pathogens and Characterise Emerging Infections, coordinated by Singapore’s National Centre for Infectious Diseases.