Duke-NUS and GenScript Announce Notice of Allowance for U.S. Patent Application for SARS-CoV-2 Surrogate Virus Neutralization Test

GenScript Biotech Corporation, a world-leading life sciences research and application service and product provider, and Duke-NUS Medical School, a premier, research intensive medical school, announced that the U.S. Patent and Trade Office has issued a notice of allowance for the patent application for a novel Surrogate Virus Neutralization Technology (sVNT). Neutralizing antibodies have been scientifically shown to play a major role in preventing infection by blocking a virus from infecting cells.

Developed by Professor Linfa Wang and his team from Duke-NUS, the sVNT neutralization antibody detection technology is exclusively licensed to GenScript for commercialization as the cPass™ SARS-CoV-2 Neutralization Antibody Test. Another key enabler in taking the cPass test to market is the Diagnostics Development Hub, a national platform hosted by Singapore's Agency for Science, Technology and Research, which validated the kit with clinical samples, developed the manufacturing protocols and quality control processes, and secured its provisional authorization by the Health Sciences Authority in Singapore. The kit has been granted emergency use authorization by the U.S. Food and Drug Administration, and is the first and only authorized SARS-CoV-2 neutralizing antibody test product in the US.

"It took only 14 months to receive the notice of allowance, which we view as a strong validation of the innovative sVNT detection methodology," said Dr. Li Zhu, executive director and chief strategy officer of GenScript. "GenScript is honored to have been involved in the R&D and commercialization of the cPass kit. As the majority of the world is entering the post-vaccination COVID era, our focus has shifted from nucleic acid testing to neutralizing antibody detection to measure a person's immune system response to virus infection. Supported by our robust manufacturing and sales networks globally, GenScript is expanding access to cPass so that more research institutes and the public across countries and regions may benefit from this innovative technology."

Associate Professor Christopher Laing, Senior Associate Dean for Innovation and Entrepreneurship at Duke-NUS, said, "This is an encouraging development, as the cPass kit is a useful tool in our continuing battle against COVID-19. With its wide-ranging applications from contact tracing to monitoring the effectiveness of vaccine programs, longevity of protective immunity, and suitability of convalescent plasma for therapy, this novel detection system plays an important role in managing the COVID-19 pandemic."

The cPass test is a safer, faster, easier and more consistent alternative to the traditional live virus- or cell-based tests, with comparable specificity and sensitivity. According to clinical data published in Nature Biotechnology, the sVNT serological detection method was able to detect neutralizing antibodies from patients with 99.93% specificity and 95%-100% sensitivity.

The test does not require a biosafety level 3 facility and can test 96 samples within an hour, significantly reducing the time required for virus detection during experiments.  The fact that the kit can be used to assess immunity to multiple coronaviruses including SARS-CoV-2 and its variants makes it one of the most suitable testing tools for large-scale vaccine trials.

Duke-NUS has also filed patent applications for the sVNT technology in China, Europe and Brazil. The cPass detection kit is CE marked in Europe, allowing it to be sold freely in any part of the European Economic Area. It has received HSA provisional approval in Singapore, ANVISA in Brazil, ANMAT in Argentina, and recently has been approved by the Ministry of Health and Prevention (MOHAP) in the United Arab Emirates as a medical device. As a result, the kit has built its presence and is widely recognized in Asian, African, European and American markets.

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 nine 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. 

About GenScript Biotech Corporation

GenScript Biotech Corporation (Stock Code: 1548.HK) is the world's leading technology and service provider of life science R&D and manufacture, founded in New Jersey, US in 2002. Built upon its solid gene synthesis technology, GenScript is divided into four major platforms including the life science service and product platform, the biologics contract development and manufacturing organization (CDMO) platform, the global cell therapy platform and the industrial synthesis biological product platform, providing premium, convenient and reliable services and products for over 100,000 customers worldwide. Driven by the corporate mission of "making people and nature healthier through biotechnology", GenScript strives to become the most trustworthy biotech company in the world.

About the Diagnostics Development (DxD) Hub

The Diagnostics Development (DxD) Hub is a national initiative in Singapore, led by the Agency for Science, Technology and Research (A*STAR).  The DxD Hub aims to accelerate the transformation of innovations into clinically validated diagnostic devices that are ready for market adoption.  Through impactful products, empowering local enterprises and anchoring global companies in Singapore, the DxD Hub contributes to the development of an effective diagnostic devices ecosystem in Singapore.

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. Through open innovation, we collaborate with our partners in both the public and private sectors to benefit the economy and 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 improving societal outcomes in healthcare, urban living, and sustainability. A*STAR plays a key role in nurturing scientific talent and leaders for the wider research community and industry. A*STAR's R&D activities span biomedical sciences to physical sciences and engineering, with research entities primarily located in Biopolis and Fusionopolis.