GenScript Announces Notice of Allowance for U.S. Patent Application for SARS-CoV-2 Surrogate Virus Neutralization Kit

GenScript Biotech Corporation, a world-leading life sciences research and application service and product provider, announced that the U.S. Patent and Trademark Office (USPTO) has issued a notice of allowance for a patent application covering a novel Surrogate Virus Neutralization Test (sVNT). This is the second notice of allowance by the USPTO related to the sVNT technology that GenScript's cPass™ SARS-CoV-2 Neutralization Antibody Test is based on.

Developed by Dr. Linfa Wang and his team at Duke-NUS Medical School, the sVNT was exclusively licensed to GenScript for commercialization as the cPass test. The cPass test specifically identifies the presence of neutralizing antibodies after vaccination or infection. Neutralizing antibodies have been scientifically shown to play a major role in preventing COVID-19 infection by blocking the virus from infecting the host cells. The cPASS kit has been granted emergency use authorization by the U.S. Food and Drug Administration and is the only authorized SARS-CoV-2 neutralizing antibody test product in the US.

"We are pleased that the U.S. Patent and Trademark Office continues to recognize the importance of the cPass test and the role this novel technology plays in the fight against the COVID-19 pandemic," said Dr. Michael Lau, global head of commercialization for diagnostics at GenScript. "The cPass test lets individuals know if they have neutralizing antibodies after vaccination against COVID-19 or previous infection. All other FDA authorized serology tests on the market identify all the antibodies generated after vaccination or infection but can not determine if the patient has generated neutralizing antibodies."

The presence and level of neutralizing antibodies, which can decline over time, is an important indicator of the potential for re-infection. By providing the level of neutralizing antibodies in a vaccinated and previously infected individual, cPass enables better-informed decisions about whether a booster shot is needed. The cPass test can also be used to assess neutralizing antibodies for different SARS-CoV-2 variants.

cPass is commercialized in the U.S. as an ELISA-based semi-quantitative assay using plasma or serum samples. It can be performed in roughly 1 hour with simple ELISA readers. In addition, GenScript has tested the same product with finger-prick derived whole blood and found similar efficacy. With global strategic partners, GenScript is in the process of launching new product lines, including a chemiluminescent-based high-throughput assay, and a lateral flow-based 15-min home-use assay.

The only FDA-authorized serology test to detect the presence or absence of neutralizing antibodies, cPass is a more efficient alternative to traditional, highly complex cell-based assays. According to clinical data published in Nature Biotechnology, sVNT was able to detect neutralizing antibodies from patients with 99.93% specificity and 95%-100% sensitivity, with live-virus assay as the comparator. The cPass test does not require a biosafety level 3 facility and can test up to 92 samples per hour, significantly reducing the time required for neutralizing antibody detection..

Duke-NUS has also filed patent applications for the sVNT in China, Europe and Brazil. The cPass 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 recognized in Asian, African, European and American markets.

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.