GenScript Submits Application with FDA for Use of cPass™ SARS-CoV-2 Neutralization Antibody Test in Convalescent Plasma Screening

PISCATAWAY,N.J.,Jan. 13,2021 -- GenScript USA Inc.,the world's leading research reagent provider,announced today that it has submitted an application to the U.S. Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) for use of the cPass™ SARS-CoV-2 Neutralization Antibody Detection Kit in convalescent plasma screening. The kit,which has been authorized by the FDA for emergency use in clinical diagnostics laboratories,is the first commercially available product to specifically detect COVID-19 neutralizing antibodies without the use of live virus. Neutralizing antibodies block the ability of the virus to infect a cell and are widely recognized biomarkers of immunity.

Convalescent plasma from patients who have recovered from COVID-19 may contain antibodies that fight the virus and is often used as a transfusion treatment for patients hospitalized with COVID-19 to speed recovery. However,successful treatment with convalescent plasma has been variable and new tools are needed to help gauge its effectiveness.

"The cPass is a valuable assay for identifying the functionality and level of antibodies in convalescent plasma prior to its use in treatment," said David Martz,vice president of new product management in the Life Science Group at GenScript. "Convalescent plasma that contains functionally active antibodies that neutralize COVID-19 - rather than binding antibodies that don't block the virus - could be more effective than plasma with low or no neutralizing antibodies. This could potentially increase the effectiveness of convalescent plasma treatment,helping patients to recover more quickly."

The novel cPass test detects neutralizing antibodies in patient samples without the use of live virus. The conventional method of measuring neutralizing antibodies in patient samples requires the use of live cells and a high safety level environment (BSL3). Obtaining results also takes multiple days. In contrast,the cPass™ kit utilizes pure proteins and can be performed in most standard laboratories with a short turnaround time (~1hr).

The cPass kit is also CE marked,and authorized by ANVISA and Health Sciences Authorities in Singapore.

GenScript remains committed to supporting the healthcare community in combatting COVID-19 infections,with a broad portfolio of research and development tools and diagnostics,including the novel cPass kit.

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 was 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.

For more information visit www.genscript.com.

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