Industry News: GenScript obtains CE-IVD mark for SARS-CoV-2 diagnostic products

The cPass™ – SARS-CoV-2 Surrogate Virus Neutralization Test (sVNT) Kit aims to detect the presence of neutralizing antibodies in an hour

27 May 2020


GenScript Biotech Europe BV has announced that it has obtained CE marking for its SARS-CoV-2 diagnostic products to be sold as an in vitro diagnostic (“IVD”). Among these products is the novel cPass™ – 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. This is a major advance in understanding the epidemiology of the disease and if individuals have developed neutralizing antibodies that may confer immunity.

cPass - SARS-CoV-2 Surrogate Virus Neutralization test kit

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.

Dr. Wang said, "The cPass™ Test Kit can be used for contact tracing, reservoir or intermediate animal tracking, assessment of herd immunity, the longevity of protective immunity and efficacy of different vaccine candidates. It does not require a biosafety containment facility, which makes it immediately accessible to the global community, including many developing nations".

"Acquiring the CE-IVD mark expands the market opportunity for our detection kits in the EU and other major international markets," said Patrick Liu, President of GenScript Biotech Europe BV. "I hope cPass™Test Kit will play a critical role in the global efforts of overcoming the pandemic.”

Together with the other CE-IVD tests GenScript offers including qRT-PCR detection kits and IgG & 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.

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