Policy & Regulation
GenScript Biotech Receives CE-IVD for Its Neutralizing Antibody Test Kit of SARS-CoV-2 and COVID-19 Diagnostic Products
27 May 2020 - - Netherlands-based GenScript Biotech Europe BV has obtained CE marking for its SARS-CoV-2 diagnostic products to be sold as an in vitro diagnostic, the company said.

Among these products is the novel cPass SARS-CoV-2 Surrogate Virus Neutralization Test Kit which detects the presence of neutralizing antibodies in an hour and does not require live biological materials or biosafety containment for testing.

This is a major advance in understanding the epidemiology of the disease and if individuals have developed neutralizing antibodies that may confer immunity.

The surrogate Virus Neutralization test kit is the result of an exclusive co-development agreement between Dr. Linfa Wang at Duke –NUS Medical School in Singapore, GenScript Biotech Corp., and the Diagnostics Development Hub at Singapore's Agency for Science Technology and Research (A*STAR).

Dr. Linfa Wang, a virologist, epidemiologist, and director of the Emerging Infectious Disease program at Duke-NUS Medical School is one of the world's leading experts on emerging zoonotic viruses. Dr. Wang serves on multiple World Health Organization committees focused on COVID-19 and is the principal investigator of the collaboration.

GenScript went through the proof of concept research, product design, development, and optimization, working with Dr. Wang and the A*STAR team. GenScript now plays a central role in the commercialization process using its global network and manufacturing capabilities.

Together with the other CE-IVD tests GenScript offers including qRT-PCR detection kits and IgG and IgM serological testing kits, one can monitor the complete infection history of a person, from initial infection through the different stages of infection to the point of monitoring neutralizing antibodies as an indicator of future immunity against the virus.

GenScript is a global biotechnology group providing gene, peptide, protein, CRISPR, and antibodies to scientists in more than 100 countries.

Since its founding in 2002, GenScript has grown exponentially through partnerships with scientists conducting fundamental life science and translational biomedical research, as well as early-stage pharmaceutical development.

With a mission to improve the health of mankind and nature through biotechnology, the company has developed the best-in-class capacity and capability for producing biological reagents.
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