
GenScript announced CE-IVD for neutralizing antibody test kit of SARS-CoV-2 and COVID-19 diagnostics
On May 26, 2020, GenScript Biotech announced that it had obtained CE-IVD for its SARS-CoV-2 diagnostic products to be sold as an in vitro diagnostic. Among these products was the novel cPass SARS-CoV-2 Neutralization Antibody Detection Kit, also known as SARS-CoV-2 Surrogate Virus Neutralization Test (sVNT) Kit, which detects the presence of neutralizing antibodies in an hour and does not require live biological materials or biosafety containment for testing.
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 Corporation, and the Diagnostics Development Hub (DxD) 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 (WHO) 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.
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Source: GenScript Biotech
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