PISCATAWAY, NJ, 11 February 2021 / PRNewswire / – GenScript USA Inc., the world’s leading instrument and service provider for life science research, announced today that it has received an emergency permit from the U.S. Food and Drug Administration’s Center for Biological Evaluation and Research (CBER) for the use of the cPass ™ SARS-CoV-2 detection kit for neutralizing antibodies in recycled plasma screening. The cPass kit is the first FDA-authorized test that specifically detects COVID-19 neutralizing antibodies without the use of live virus. Neutralizing antibodies block the virus’ ability to infect a cell and are widely recognized biomarkers of immunity.
“Since the cPass kit was approved by the FDA for emergency use late last year, more than 300 organizations have adopted it to detect these critical antibodies,” he said. David Martz, vice president of new product management in the Life Science Group at GenScript. “We are excited to expand the use of this plasma treatment recovery test and look forward to bringing it to healthcare facilities to increase the effectiveness of plasma treatment recovery, and ultimately help patients recover faster from COVID-19. “
Recovery plasma from patients recovering from COVID-19 may contain antibodies that fight the virus and is often used as a transfusion treatment for patients hospitalized with COVID-19. However, successful treatment with recovery plasma has been volatile and new tools are needed to determine its effectiveness. The cPass kit identifies the functionality and level of antibodies in recovery plasma before use during treatment. Recovery plasma containing functionally active antibodies that neutralize COVID-19 – rather than binding antibodies that do not block the virus – may be more effective than plasma with low or no neutralizing antibodies.
“Neutralizing antibodies are the first line of defense against SARS CoV-2 infection by blocking the virus from binding to host cells and thus inhibiting viral reproduction. The cPass test specifically detects neutralizing antibodies after vaccination to elicit a robust, effective and long-lasting immune response assured. ”said Sean Taylor, scientific manager at GenScript. ” A newly published article in the Journal of Clinical Microbiology describes and contrasts this new, high throughput assay with other commercial IgG-specific and live virus neutralization assays, arguing for its use in immunoassaying infected, recovered and vaccinated individuals as well as restorative plasma screening. ”
The new cPass test detects neutralizing antibodies in patient samples without the use of live virus. The conventional method of measuring neutralizing antibodies in the patient samples requires the use of live cells, and obtaining results takes several days and a high safety level environment (BSL3). In contrast, the cPass kit uses pure proteins that can be performed in most standard laboratories with a short cycle time (~ 1 hour).
In addition to the FDA EUA, the cPass kit is CE marked in Europe, authorized by ANVISA in BrazilHealth Sciences Authorities Singapore and Ministry of Health and Prevention in the United Arab Emirates. GenScript is still committed to supporting the global healthcare community in the fight against COVID-19 infections, with a broad portfolio of research and development tools and diagnostics, 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 major platforms, including the global cell therapy platform, the CDMO (Biological Contract Development and Manufacturing Organization) platform, the CRO (Contract Research Organization) platform and the Industrial Synthesis platform.
GenScript was founded in New jersey, US in 2002 and listed on the Hong Kong Stock Exchange in 2015. GenScript’s business spans more than 100 countries and regions worldwide, with legal entities in the US, China, Hong Kong, Japan, Singapore, The Netherlands and Ireland. GenScript has provided premium, convenient and reliable products and services to more than 100,000 customers.
GenScript has 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’s products and services are cited by 52,500 peer-reviewed journal articles worldwide.
Visit www.genscript.com for more information.
SOURCE GenScript USA Inc.
