GenScript and Duke-NUS Announce Allocation Notice for “Surrogate Virus Neutralization Technology”
GenScript Biotech Corporation (“GenScript”, action code: 1548.HK), a global leader in life sciences research and applications services and product supplier, and Duke-NUS Medical School, a medical school leading research-intensive, announced today that the United States Patent and Trade Office has issued a notice of acceptance of 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 preventing the virus from infecting cells.
Developed by Professor Linfa Wang and his team at Duke-NUS, sVNT neutralizing antibody detection technology is exclusively licensed from GenScript for commercialization as the cPass ™ SARS-CoV-2 neutralizing antibody test. .
Another key element in the commercialization of the cPass test is the Diagnostics Development Hub, a national platform hosted by the Singapore 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 clearance from the Health Sciences Authority of 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. “
Dr Li Zhu, Executive Director and Chief Strategy Officer, 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 global manufacturing and sales networks, GenScript is expanding access to cPass so that more research institutes and the public across countries and regions can 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 many applications of contact tracing to monitor 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 the management of the COVID-19 pandemic. “
The cPass test is a safer, faster, easier 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 neutralizing antibodies from patients 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 an 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 also CE marked in Europe, which allows it to be sold freely in any part of the European Economic Area. It has received provisional approval from 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 as medical device. As a result, the kit has built its presence and is widely recognized in Asian, African, European and American markets.