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PISCATAWAY, NJ, February 11, 2021 / PRNewswire / – GenScript United States Inc., the world’s leading provider of life science research tools and services, announced today that it has received emergency use authorization from the Center for Biologics Evaluation and Research (CBER) of the United States Food and Drug Administration for the use of cPass ™ SARS-CoV-2 Neutralization Antibody Detection Kit in the screening of convalescent plasma. The cPass Kit is the first FDA-cleared test that specifically detects COVID-19 neutralizing antibodies without using live virus. Neutralizing antibodies block the ability of the virus to infect a cell and are widely recognized biomarkers of immunity.
“Since the cPass kit was cleared for emergency use by the FDA late last year, more than 300 organizations have adopted it to detect these critical antibodies,” said David Martz, vice president of new product management at Life Science Group at GenScript. “We are excited to to expand the use of this assay for recovering plasma screening and we look forward to bringing it to healthcare facilities to help increase the effectiveness of convalescent plasma treatment, ultimately helping patients to recover faster from COVID-19. “
Convalescent plasma from patients who have recovered from COVID-19 may contain antibodies that fight the virus and is often used as a transfusion therapy for patients hospitalized with COVID-19 to speed recovery. However, the success of convalescent plasma treatment has been variable and new tools are needed to help assess its effectiveness. The cPass Kit identifies functionality and antibody level in convalescent plasma prior to its use in therapy. Convalescent plasma that contains functionally active antibodies that neutralize COVID-19 – rather than binding antibodies that do not block the virus – might be more effective than plasma with little or no neutralizing antibodies.
“Neutralizing antibodies represent the first line of defense against SARS CoV-2 infection by blocking virus binding to host cells, thereby inhibiting viral spread. The cPass test specifically detects neutralizing antibodies after vaccination to ensure robust, effective and prolonged immune response ”, added Sean taylor, scientific manager at GenScript. “A recently published article in the Journal of Clinical Microbiology describes and compares this new high-throughput test with other commercial IgG-specific and live virus neutralization tests, justifying its use in the immune surveillance of infected, recovered and vaccinated as well as convalescent plasma screening. ”
The new cPass test detects neutralizing antibodies in patient samples without using live virus. The conventional method of measuring neutralizing antibodies in patient samples requires the use of living cells and obtaining results takes several days and a high security environment (BSL3). In contrast, the cPass kit uses pure proteins which can be made in most standard laboratories with a short processing time (~ 1 h).
In addition to the FDA EUA, the cPass the kit is CE marked Europe, authorized by ANVISA in Brazil, Health Sciences Authorities in Singapore and Ministry of Health and Prevention in the United Arab Emirates. GenScript remains committed to supporting the global health community in the fight against 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 advanced gene synthesis technology, GenScript has developed four major platforms, including the Global Cell Therapy Platform, Biological Contract Manufacturing and Development Organization (CDMO) Platform , the Contract Research Organization (CRO) Platform and the Industrial Synthesis Products Platform.
GenScript was founded in New Jersey, United States in 2002 and listed on the Hong Kong Stock Exchange in 2015. GenScript’s business operations span over 100 countries and regions around the world, with legal entities located in the United States, 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 owns a number of 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 have been cited by 52,500 peer-reviewed journal articles worldwide.
For more information, visit www.genscript.com.
SOURCE GenScript United States Inc.
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