News | June 3, 2020

GenScript Files For Emergency Use Authorization Of Rapid SARS-CoV-2 Neutralization Antibody Detection Kit

cPass™ test can be performed within an hour in standard laboratories without the need for live virus

Piscataway, NJ /PRNewswire/ - GenScript Biotech Corp., the world's leading research reagent provider, announced today that the company has filed for Emergency Use Authorization (EUA) with the U.S. Food and Drug Administration (FDA) to market its cPass™ SARS-CoV-2 Neutralization Antibody Detection Kit. This is the first test submitted for regulatory approval that specifically detects neutralizing antibodies to SARS-CoV-2, the virus that causes COV-19, without the use of live virus. Current serological antibody tests identify prior exposure to the virus by detecting the presence of antibodies from an immune response, but do not indicate whether these antibodies are neutralizing antibodies.

A virus neutralization test detects the presence of neutralizing antibodies, which are key biomarkers of immunity and act to protect the body by blocking the virus's entry into the cell. Traditional virus neutralization tests require live virus and cells and must be performed in a biosafety containment facility staffed by highly skilled personnel, with results often taking days. The cPass kit enables detection of neutralizing antibodies within an hour, without the need for live virus and biosafety containment, making it broadly available to standard labs in hospitals and clinics. The kit, which is compatible with both manual, automated and high-throughput immunoassay workflows such as ELISA, has received CE marking for commercial use as an in vitro diagnostic product in Europe.

"GenScript's cPass kit would be a valuable tool in our fight against the SARS-CoV-2 outbreak, providing laboratories with a fast, accurate method of testing for neutralizing antibodies against this virus," said David Martz, vice president of new product management in Life Science at GenScript. "We believe that the cPass test kit could be critical in assessing herd immunity, durability of protective immune response and efficacy of SARS-CoV-2 vaccine candidates."

Besides detecting neutralizing antibodies, the cPass kit is species-independent and isotope-independent, enabling scientists and clinicians to screen antibodies derived from any source, such as rabbits, ferrets and other animals, for zoonotic surveillance research. It employs novel technology invented by Professor Wang Linfa, director of Duke-National University of Singapore's Emerging Infectious Diseases program, and team. The cPass kit has also been validated with samples of patients from PROTECT, a multi-centered Prospective Study to Detect Novel Pathogens and Characterize Emerging Infections, coordinated by Singapore's National Centre for Infectious Diseases and granted Singapore's Health Sciences Authority's (HSA) provisional authorization for clinical use.

"The cPass kit is yet another example of GenScript's continued commitment to combatting SARS-CoV-2," Martz added. "We are actively working on commercializing our test globally and look forward to helping communities as they respond to this ongoing pandemic."

About GenScript Biotech Corporation
GenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Based on its leading gene synthesis technology, GenScript has developed four major platforms including the global cell therapy platform, the biologics contract development and manufacturing organization (CDMO) platform, the contract research organization (CRO) platform and the industrial synthesis product platform.

GenScript was founded in New Jersey, US in 2002 and listed on the Hong Kong Stock Exchange in 2015. GenScript's business operation spans over 100 countries and regions worldwide, with legal entities located in the U.S., Mainland China, Hong Kong, Japan, Singapore, Netherlands and Ireland. GenScript has provided premium, convenient, and reliable products and services for over 100,000 customers.

GenScript has a number of intellectual property rights and technical secrets, including more than 100 patents and over 270 patent applications. As of December 31, 2019, GenScript's products and services have been cited by 42,200 peer-reviewed journal articles worldwide.

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Source: GenScript Biotech Corporation

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