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May 27, 2020

GenScript Biotech secures CE-IVD for Covid-19 diagnostic products

GenScript Biotech Europe has received CE-IVD for its neutralising antibody test kit of SARS-CoV-2 diagnostic products to be sold as an in vitro diagnostic (IVD).

GenScript Biotech Europe has received CE-IVD for its neutralising antibody test kit of SARS-CoV-2 diagnostic products to be sold as an in vitro diagnostic (IVD).

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The products include cPass SARS-CoV-2 Surrogate Virus Neutralization Test (sVNT) Kit, which detects the presence of neutralising antibodies in an hour without requiring live biological materials or biosafety containment for testing.

The company noted that the test is a major advance in understanding the epidemiology of the disease and if individuals have developed neutralising antibodies that may confer immunity.

GenScript Biotech Europe president Patrick Liu said: “Acquiring the CE-IVD mark expands the market opportunity for our detection kits in the EU and other major international markets.

“I hope cPass Test Kit will play a critical role in the global efforts of overcoming the pandemic.”

The test was co-developed by Duke-NUS Medical School, GenScript Biotech Corporation and Singapore’s Agency for Science, Technology and Research (A*STAR).

Duke-NUS Medical School Emerging Infectious Diseases programme director Dr Wang Linfa 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.”

GenScript also offers qRT-PCR detection kits and IgG & IgM serological testing kits.

The tests together with other CE-IVD tests are said to deliver complete infection history of a person, from initial infection to the point of monitoring neutralising antibodies as an indicator of future immunity against the virus, the company said.

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COVID-19 has already affected our lives forever. The way we work, shop, eat, seek medical advice, and socialize will all be different in the future. Quite how different remains to be seen, but all industries must plan for multiple eventualities. Are you interested in actionable insights on the business challenges induced by the pandemic? GlobalData's cross-sector report analyzes the significance of this major disruptive theme across industry verticals. It provides side-by-side research of alternative datasets to present you with unique quantitative analysis of the effects of COVID-19 and how these differ across sectors. Additionally, it offers qualitative analysis of each sector and analyzes COVID-19’s impact on leading companies. Whatever your company’s imminent strategic plans, the long-lasting impact of COVID-19 must not be overlooked. Find out how to futureproof your business operations – download our report today.
by GlobalData
Enter your details here to receive your free Report.

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