SINGAPORE,May 14, 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) atSingaporesAgency for Science, Technology and Research (A*STAR), today announced an exclusive agreement to co-develop and manufacture a unique serological coronavirus (COVID-19) detection system known as the surrogate virus neutralisation test (sVNT) or cPass. This test is the first in the world that allows rapid detection of neutralising 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. 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, DirectorofDuke-NUS Emerging Infectious Diseases programme, and team conceived this research and invented the cPassdiagnostic test. The team also did the assay development and testing inSingapore.

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 inSingaporeand other regions around the world.

DxD Hub is a national initiative led by A*STARs 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 inSingaporehospitals. 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.

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, saidProfessor Patrick Casey, Senior Vice Dean of Research at Duke-NUS.

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 ProfessorThomas M. Coffman, Dean of Duke-NUS.

Dr ZhuLi, Chief Strategy Officer of GenScriptadded, 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 serveSingaporemarket 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, saidJohnson Wang, President in Asia Pacific Region at GenScript.

Sherry Shao, President of Life Science Group at GenScript echoed, The collaboration with Duke-NUS is a key example of how global industry and academia work together to make things happen. Leveraging the leading technologies in molecular biology, protein science and immunology, we help our partners in virus mapping, detection, treatment and vaccine development. GenScript is committed to fighting the pandemic with the world.

DrSidney Yee, CEO of DxD Hub said: As Singapores 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 bySingaporesNational Centre for Infectious Diseases.

About Duke-NUS Medical School

Duke-NUS isSingaporesflagship graduate entry medical school, established in 2005 with a strategic, government-led partnership between two world-class institutions:Duke UniversitySchool of Medicine and theNational University of Singapore(NUS). Through an innovative curriculum, students at Duke-NUS are nurtured to become multi-faceted Clinicians Plus poised to steer the healthcare and biomedical ecosystem inSingaporeand beyond. A leader in ground-breaking research and translational innovation, Duke-NUS has gained international renown through its five signature research programmes and eight centres. The enduring impact of its discoveries is amplified by its successful Academic Medicine partnership with Singapore Health Services (SingHealth),Singaporeslargest healthcare group. This strategic alliance has spawned 15 Academic Clinical Programmes, which harness multi-disciplinary research and education to transform medicine and improve lives.

For more information, please visitwww.duke-nus.edu.sg.

About GenScript Biotech Corporation

GenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Based on its leading gene synthesis technology, GenScript has developed four major platforms including the global cell therapy platform, the biologics contract development and manufacturing organisation (CDMO) platform, the contract research organisation (CRO) platform and the industrial synthesis product platform.

GenScript was founded inNew Jersey, US in 2002 and listed on the Hong Kong Stock Exchange in 2015. GenScripts business operation spans over 100 countries and regions worldwide with legal entities located in the US, Mainland China,Hong Kong,Japan,Singapore,NetherlandsandIreland. GenScript has provided premium, convenient, and reliable products and services for over 100,000 customers.

GenScript has a number of intellectual property rights and technical secrets, including more than 100 patents and over 270 patent applications. As ofDecember 31, 2019, GenScripts products and services have been cited by 42,200 peer-reviewed journal articles worldwide.

For more information visitwww.genscript.com.

About the Agency for Science, Technology and Research (A*STAR)

The Agency for Science, Technology and Research (A*STAR) isSingaporeslead public sector R&D agency, spearheading economic-oriented research to advance scientific discovery and develop innovative technology. Through open innovation, we collaborate with our partners in both the public and private sectors to benefit society.As a Science and Technology Organisation, A*STAR bridges the gap between academia and industry. Our research creates economic growth and jobs forSingapore, and enhances lives by contributing to societal benefits such as improving outcomes in healthcare, urban living, and sustainability. We play a key role in nurturing and developing a diversity of talent and leaders in our Agency and research entities, the wider research community and industry. A*STARs R&D activities span biomedical sciences and physical sciences and engineering, with research entities primarily located in Biopolis and Fusionopolis. For ongoing news, visitwww.a-star.edu.sg.

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For media enquiries, please contact:

Lekshmy Sreekumar, Ph.D.CommunicationsDuke-NUS Medical SchoolTel: +65 65161138Email:lekshmy_sreekumar@duke-nus.edu.sg

Aloe XueCommunicationsGenScript Biotech CorporationTel: +10 (25) 5889 7288 ext. 6318Email:aloe.xue@genscript.com

MsLynn HongA*STAR Corporate CommunicationsTel: +65 9764 0438hongxl@hq.a-star.edu.sg

For commercial enquiries, please contact:GenScript DiagnosticsTel: +1 (732) 317-5055Email:CovidKits@genscript.com

SOURCE GenScript Biotech Corporation

http://www.genscript.com

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