GenScript Biotech Corporation ("GenScript", Stock Code: 1548.HK), a world-leading life sciences research and application service and product provider, and Duke-NUS Medical School, a premier, research intensive medical school, announced today 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 major role in preventing infection by blocking the virus from infecting the cells.
Developed by Professor Linfa Wang and his team from Duke-NUS, the sVNT neutralization antibody detection technology is exclusively licensed to GenScript for commercialisation as the cPass™ SARS-CoV-2 Neutralisation 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 authorisation by the Health Sciences Authority in Singapore.
The kit has been granted emergency use authorisation by the U.S. Food and Drug Administration, and is the first and only authorised SARS-CoV-2 neutralising 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."
Dr. Li Zhu, Executive Director and Chief Strategy Officer, GenScript
"GenScript is honored to have been involved in the R&D and commercialisation 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 neutralising 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 programmes, 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 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 neutralising 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 also 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 recognised in Asian, African, European and American markets.