GenScript Biotech gets CE-IVD mark for SARS-CoV-2 diagnostic products

The novel cPass – SARS-CoV-2 Surrogate Virus Neutralisation Test enables to identify the presence of neutralising antibodies in an hour

GenScript Biotech Europe has secured CE mark approval for its SARS-CoV-2 diagnostic products to market as in vitro diagnostic (IVD) products.

The novel cPass – SARS-CoV-2 Surrogate Virus Neutralisation Test (sVNT) kit is one of the products designed to identify the presence of neutralising antibodies in an hour. It also helps to avoid the use of live biological materials or biosafety containment for testing.

The surrogate Virus Neutralisation test kit was developed under an exclusive co-development agreement between Dr Linfa Wang at Duke –NUS Medical School in Singapore, GenScript Biotech and the Diagnostics Development Hub (DxD) at Singapore’s Agency for Science Technology and Research (A*STAR).

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.”

GenScript has taken the responsibility for the proof of concept research, product design, development, and optimisation of the surrogate Virus Neutralisation test kit.

GenScript claimed that it will also play a significant role in the commercialisation process using its global network and manufacturing capabilities.

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

GenScript offers qRT-PCR detection kits and IgG & IgM serological testing kits, in addition to other CE-IVD tests.

The tests allow to better monitor the complete infection history of a person ranging from initial infection through the different stages of infection to the point of monitoring neutralising antibodies as an indicator of future immunity against the virus, said the company.

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.” – NSMedical

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