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

PISCATAWAY, NJ and SINGAPORE, June 21, 2021 / PRNewswire / – GenScript Biotech Corporation (“GenScript”, action code: 1548.HK), a leading global provider of life sciences research and applications services and products, and Duke- NUS Medical School, a leading research-intensive medical school, today announced that the United States Patent and Trade Office has issued a notice of release for the patent application for new neutralization technology surrogate viruses (sVNT). Neutralizing antibodies have been scientifically shown to play a major role in preventing infection by preventing a virus from infecting cells.

Developed by the teacher Linfa Wang and its team at Duke-NUS, sVNT neutralizing antibody detection technology is exclusively licensed to GenScript for commercialization as the cPass ™ SARS-CoV-2 neutralizing antibody test. The Diagnostics Development Hub, a national platform hosted by that of Singapore Agency for Science, Technology and Research, which validated the kit with clinical samples, developed manufacturing protocols and quality control processes, and obtained provisional clearance from the Health Sciences Authority in Singapore. The kit has received emergency use clearance from the United States Food and Drug Administration and is the first and only SARS-CoV-2 neutralizing antibody test product authorized in the United States.

“It only took 14 months to receive the allocation notice, which we see 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 enters the post-COVID vaccination era, our focus has shifted from nucleic acid testing to detecting neutralizing antibodies to measure a person’s immune system. system response to viral infection. Backed by our strong manufacturing and sales networks around the world, GenScript is expanding access to cPass so that more research institutes and the public in all countries and regions can benefit from this innovative technology.

Associate Professor Christophe 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 many applications ranging from contact tracing to monitoring the effectiveness of vaccination programs, the longevity of protective immunity and the suitability of convalescent plasma for therapy, this new detection system plays an important role in management of the COVID-19 pandemic. “

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

The assay does not require a Biosafety Level 3 facility and can test 96 samples in one hour, significantly reducing the time required for virus detection during experiments. The fact that the kit can be used to assess immunity to several 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 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 received interim approval from the HSA in Singapore, ANVISA in Brazil, ANMAT in Argentina, and was recently 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 School of Medicine

Duke-NUS is that of Singapore A flagship graduate entry medical school, established in 2005 with a government-led strategic partnership between two world-class institutions: duke university School of Medicine and national university of singapore (NUS). Through an innovative program, Duke-NUS students are encouraged to become multifaceted ‘Clinicians Plus’ ready to lead the health and biomedical ecosystem in Singapore and beyond. A leader in groundbreaking research and translational innovation, Duke-NUS has gained international recognition through its five research programs and nine centers. The lasting impact of its discoveries is amplified by its successful academic medicine partnership with Singapore Health Services (SingHealth), that of Singapore largest healthcare group. This strategic alliance has spawned 15 academic clinical programs, which harness multidisciplinary 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 the world’s leading provider of life science R&D and manufacturing technologies and services, founded in New Jersey, United States in 2002. Building on its strong gene synthesis technology, GenScript is divided into four main platforms, including the life sciences products and services platform, the d ‘Biologics Development and Manufacturing Organization (CDMO), the global cell therapy platform and biologics platform, providing premium, convenient and reliable products and services to over 100,000 customers in the world. Driven by the company’s mission to “make people and nature healthier through biotechnology,” GenScript strives to be the world’s most trusted biotech company.

For more information, please visit https://www.genscript.com.

About the Diagnostic Development Center (DxD)

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 ready for market adoption. Through impactful products, empowering local businesses and anchoring global businesses Singapore, the DxD Hub contributes to the development of an efficient ecosystem of diagnostic devices in Singapore.

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

The Agency for Science, Technology and Research (A * STAR) is that of Singapore leading public sector R&D agency. Through open innovation, we collaborate with our partners in the public and private sectors for the benefit of the economy and society. As a science and technology organization, A * STAR bridges the gap between academia and industry. Our research creates economic growth and jobs for Singapore, and improves 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 broader research community and industry. A * STAR’s R&D activities range from biomedical sciences to physical sciences and engineering, with research entities mainly located in Biopolis and Fusionopolis. For current news, visit www.a-star.edu.sg.

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