AsiaNet  84087

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

SINGAPORE, May 20, 2020 /PRNewswire=KYODO JBN/ --

-- As a first-in-the-world "rapid smart test kit", the cPass™ 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 cPass™ 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.

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 15th May 2020 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. The cPass™ 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 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 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.

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.

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.

"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," said Professor

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 Professor Thomas M. Coffman, Dean of Duke-NUS.

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.

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."

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.

About Duke-NUS Medical School

Duke-NUS is Singapore's flagship graduate entry medical school, established in

2005 with a strategic, government-led partnership between two world-class

institutions: Duke University School of Medicine and the National 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 in Singapore and 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),

Singapore's largest 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 visit www.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 in New Jersey, US in 2002 and listed on the Hong Kong

Stock Exchange in 2015. GenScript's business operation spans over 100 countries

and regions worldwide with legal entities located in the US, Mainland China,

Hong Kong, Japan, Singapore, Netherlands and Ireland. 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 of

December 31, 2019, GenScript's products and services have been cited by 42,200

peer-reviewed journal articles worldwide.

For more information visit www.genscript.com.

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

The Agency for Science, Technology and Research (A*STAR) is Singapore's lead

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 for Singapore, 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*STAR's R&D activities span biomedical sciences and

physical sciences and engineering, with research entities primarily located in

Biopolis and Fusionopolis. For ongoing news, visit www.a-star.edu.sg.

Source:  Genscript