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INSIDE INDUSTRY
Detecting Neutralising Antibodies with World’s first SARS-CoV-2 Serology Test
Duke-NUS, GenScript and A*STAR from Singapore launch the firt-in-the-world rapid test kit, cPass™, able to measure neutralising antibodies in an hour for investigation and contact tracing of COVID-19.

Announced in May 2020, Duke-NUS, GenScript, and Diagnostics Development Hub (DxD) at Singapore’s A*STAR agreed to co-develop and manufacture a serological coronavirus (COVID-19) detection system known as the surrogate virus neutralisation test (sVNT) or cPass™.

This first-in-the-world test allows for rapid detection of neutralising antibodies which are specifically present in the blood serum of a COVID-19 positive patient. This kit will be the first capable of measuring functional neutralising antibodies. Conventionally, quantification of neutralising antibodies require the use of live viruses, highly-skilled operators, and complex laboratory procedures which are less sensitive and longer lead times.

The newly developed cPass™ by contrast is able to rapidly conduct the test within an hour in most research and clinical laboratories. It is also amenable for high throughput and fully automated testing after further modifications. The aim of this test is to help current COVID-19 investigations, through contact tracing to determine infection rates.

Professor Wang Linfa, Director of the 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.

Proof of concept research, product design, development and optimisation were done by GenScript which now plays a central role in the commercialisation process. Tapping into its global network and manufacturing capacity, GenScript successfully launched cPass™ in Singapore and other regions around the world.

DxD Hub played a vital role in taking cPass™ to the market through validation with clinical samples and development of the manufacturing protocol as well as quality controls to secure its provisional authorisation by the Health Sciences Authority (HSA). Production of the pilot batch for use in Singapore hospitals will also be conducted by DxD Hub, with plans to be transferred to local biotech companies to scale-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.

“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.

Dr Sidney Yee, CEO of DxD Hub said: “As Singapore’s national platform that provides end-to-end expertise in bringing diagnostic kits from bench to bedside, DxD Hub is proud to be part of this collaboration with Duke-NUS and GenScript. This innovative cPass™ diagnostic kit will be instrumental in supporting the fight against the global pandemic.”

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.

 

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