Business Wire

GENSCRIPT-BIOTECH

26.5.2020 15:02:06 CEST | Business Wire | Press release

Share
GenScript Biotech Announces CE-IVD for Its Neutralizing Antibody Test Kit of SARS-CoV-2 and COVID-19 Diagnostic Products

GenScript Biotech Europe BV 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 cPassTM – 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.

cPassTM - 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.

About GenScript
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.

Social Media:

https://www.facebook.com/genscripteurope/

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

High Awareness, Low Adoption: New Survey Reveals Nearly Half of Security Professionals Still Rely on Passwords7.10.2026 09:01:00 CEST | Press release

Global study from Yubico and Okta highlights a critical execution gap in enterprise security, shows how modern identity controls can eliminate password dependency. A new survey from Yubico (NASDAQ STOCKHOLM: YUBICO), the pioneer of phishing-resistant authentication and creator of the original passkey, the YubiKey, and Okta, Inc., reveals a significant gap between security knowledge and everyday practice. While security leaders overwhelmingly recognize phishing-resistant passkeys as more secure than passwords, nearly half still rely on vulnerable login methods in their daily work. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261007969823/en/ Conducted by Talker Research, the annual 2026 Global State of Authentication* report surveyed nearly 2,000 cybersecurity and IT professionals across nine countries. The report highlights that cybersecurity's primary vulnerability is no longer a lack of education or awareness, but a stru

Wolters Kluwer brings AI-powered drafting directly into the Libra legal workspace7.10.2026 09:01:00 CEST | Press release

In addition to Libra’s existing Word Add-in, Drafting in Libra gives customers the flexibility to choose the drafting environment that best suits their workflow, while automatically applying their firm’s existing templates Wolters Kluwer Legal & Regulatory today announced the launch of Drafting, a major new capability within Libra by Wolters Kluwer, the company’s legal AI workspace. Drafting enables legal professionals to create, edit, review, and collaborate on Word documents directly within the workspace, reducing the need to switch between separate applications throughout the drafting process. Together with Libra's existing Word Add-in, which is already widely used by legal professionals today, the new capability provides customers with a second, fully integrated way to draft their documents. Depending on their preferences and workflow, they can either remain within the Microsoft Word environment or work end-to-end in the Libra legal AI workspace. At the core of Drafting is the Libr

ClaroNav Kolahi Inc. Announces EU MDR Certification for Navient Surgical Navigation System7.10.2026 09:00:00 CEST | Press release

ClaroNav Kolahi Inc. (CKI), a global developer and manufacturer of surgical navigation technologies, today announced that its Navient Surgical Navigation System has received certification under the European Union Medical Device Regulation, EU MDR. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261007890668/en/ ClaroNav Kolahi Inc. Announces EU MDR Certification for Navient Surgical Navigation System The certification covers the Navient Image Guided Navigation System and its reusable surgical instruments, allowing CKI to continue offering Navient throughout the European Union under the EU MDR regulatory framework. “EU MDR certification is an important milestone for CKI and demonstrates our continued commitment to meeting the highest standards for safety, quality, and regulatory compliance,” said Ahmad Kolahi, CEO of CKI. Navient was previously certified under EU MDD and has received regulatory approvals including US FDA, Heal

Yapı Kredi Kripto Selects Integral to Power Digital Asset Trading Services in Türkiye7.10.2026 09:00:00 CEST | Press release

Integral's institutional-grade digital asset trading technology will support Yapı Kredi Kripto's regulated cryptocurrency offering as Türkiye's new digital asset framework comes into effect. Integral, a leading provider of currency technology, today announced that Yapı Kredi Kripto has selected Integral's digital asset trading technology, enabling the group to provide cryptocurrency services through its soon-to-launch regulated digital asset business. The partnership comes as Türkiye introduces a new regulatory framework for digital asset service providers, creating a regulated environment for financial institutions to expand their offering to customers seeking access to cryptocurrency markets. Yapı Kredi Kripto has implemented Integral's digital asset trading technology across pricing, liquidity and risk management, providing the infrastructure required to deliver a secure and efficient cryptocurrency trading experience to its customers. Integral's established presence in Türkiye was

CRH to Acquire Aggregate Operations in Denmark and Finland7.10.2026 08:24:00 CEST | Press release

Transaction Advances CRH’s Strategy to Build Aggregates-led, Connected Portfolio Aligned With Growing Infrastructure Megatrends CRH (NYSE: CRH), the leading provider of building materials, today announced that it has signed an agreement to acquire NCC Industry’s operations in Denmark and Finland from NCC AB. NCC Industry develops, produces and sells stone materials and asphalt products for construction and infrastructure projects. In Denmark NCC Industry’s national network of asphalt plants, land and marine based aggregates sites, together with its substantial high-quality reserves, will significantly expand CRH's presence in the market and its exposure to demand from major road, infrastructure and industrial projects. While in Finland NCC Industry’s attractive network of reserve backed hard-rock quarries, backfilling and recycling operations will complement CRH’s existing operations and connected portfolio of businesses in the Finnish market. Peter Buckley, President, CRH Internationa

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye