2020 AACC Annual Scientific Meeting Press Program

GenScript Granted Authorization for cPass™ SARS-CoV-2 Neutralization Antibody Detection Test in Brazil

World's first test capable of detecting virus-blocking antibodies that can be performed in standard labs in under an hour

Newswise — PISCATAWAY, NEW JERSEY, December 14, 2020 – GenScript USA Inc., the world’s leading research reagent provider, announced today that Brazil's National Health Surveillance Agency (ANVISA) (Agência Nacional de Vigilância Sanitária) has authorized the use of the cPass™ SARS-CoV-2 Neutralization Antibody Detection Kit for detecting neutralizing antibodies. The cPass test is the first and only ANVISA authorized test for detecting neutralizing antibodies to SARS-CoV-2. Neutralizing antibodies specifically block the ability of a virus to infect a cell and are well-recognized to confer immunity.

"We're extremely pleased to receive emergency use authorization in Brazil, and look forward to rapidly distributing it to labs, healthcare institutions and pharmaceutical firms across the country," said David Martz, vice president of new product management in Life Science Group at GenScript, “Because the cPass kit detects the specific antibodies that block the virus, it's a particularly valuable tool for monitoring patients for virus-blocking antibodies after they have recovered from COVID-19, as well as for determining the duration of vaccine protection post immunization."

The cPass kit is also the first and only ANVISA and EUA authorized test to specifically detect neutralizing (virus blocking) antibodies in patient samples without the use of live virus. The conventional method to measure neutralizing antibodies in the patient samples requires the use of live cells and obtaining results takes multiple days in very controlled, high safety environment (BSL3). In contrast, the cPass kit is an ELISA assay and can be performed in most standard laboratories with short turnaround time (~1hr).

Authorization for use of cPass in Brazil follows emergency use authorization of the test by the U.S. Food and Drug Administration in November, and provisional use in Singapore earlier this year. The kit has also been granted a CE Mark in Europe. And is the only neutralizing antibody test to have obtained all of these authorizations by regulatory authorities.

The cPass™ kit is another example of GenScript’s continued commitment to supporting the healthcare community in combatting COVID-19 infections.

The cPass kit is being distributed in Brazil by NL Diagnostica.

 

 

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.

For more information visit www.genscript.com.

 




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