PISCATAWAY, NJ, February 11, 2021 / PRNewswire / – GenScript USA Inc., the world’s leading provider of life science research tools and services, announced today that it has received the Emergency Use Authorization from the Food and Drug Administration’s Center for Biological Research and Evaluation (CBER) for the use of the cPass ™ SARS-CoV-2 neutralizing antibody detection kit in convalescent plasma tests. The cPass kit is the first FDA authorized test that specifically detects COVID-19 neutralizing antibodies without the use of live viruses. Neutralizing antibodies block the virus’s ability to infect a cell and are widely recognized biomarkers of immunity.
“Since the cPass kit was authorized for emergency use by the FDA at the end of last year, more than 300 organizations have adopted it to detect these critical antibodies,” said David Martz, vice president of new product management at GenScript’s Life Science Group. “We are excited for expand the use of this trial to screen for convalescent plasma and we hope to take it to health centers to help increase the effectiveness of treatment with convalescent plasma, helping patients recover more quickly from COVID-19 ”.
Convalescent plasma from patients who 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, the success of treatment with convalescent plasma has been variable and new tools are needed to help assess its effectiveness. The cPass kit identifies the functionality and level of antibodies in the convalescent plasma before use in treatment. Convalescent plasma that contains functionally active antibodies that neutralize COVID-19 – instead of binding to antibodies that do not block the virus – may be more effective than plasma with few or no neutralizing antibodies.
“Neutralizing antibodies represent the first line of defense against SARS CoV-2 infection by blocking the virus from binding to host cells, thereby inhibiting viral spread. The cPass test specifically detects neutralizing antibodies after vaccination to ensure a robust immune response, effective and prolonged, “added said Sean Taylor, GenScript scientific manager. “A newly published article in the Journal of Clinical Microbiology describes and contrasts this new high-throughput assay with other commercial tests for neutralizing live and specific IgG viruses, justifying its use in surveillance of the immunity of infected, recovered and vaccinated individuals as well. as screening for convalescent plasma. ”
The new cPass test detects neutralizing antibodies in samples from patients without the use of live viruses. The conventional method for measuring neutralizing antibodies in patient samples requires the use of live cells and obtaining the results takes several days and a high level of safety (BSL3) environment. In contrast, the cPass kit uses pure proteins that can be made in most standard laboratories with a short response time (~ 1 hour).
In addition to the US FDA, the cPass the kit has CE marking on Europe, authorized by ANVISA in Brazil, Health Sciences Authorities in Singapore and Ministry of Health and Prevention United Arab Emirates. GenScript remains committed to supporting the global health community in combating COVID-19 infections, with a broad portfolio of research and development and diagnostic tools, including the new 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 main platforms, including the global cell therapy platform, the biological contract manufacturing and development organization (CDMO) platform, the contract research organization platform ( CRO) and the industrial synthesis product platform.
GenScript was founded in New Jersey, USA in 2002 and listed on the Hong Kong Stock Exchange in 2015. GenScript’s commercial operation spans more than 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 to more than 100,000 customers.
GenScript has several intellectual property rights and technical secrets, including more than 100 patents and more than 270 patent applications. As of December 31, 2020, GenScript products and services were cited by 52,500 peer-reviewed journal articles worldwide.
For more information, visit www.genscript.com.
SOURCE GenScript USA Inc.
