Business Wire

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

Share

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.

Contact information

Jungsoo Park
jungsoo.park@genscript.com

About Business Wire

Business Wire
Business Wire



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

Spirit of Wipro Run Brings Together Thousands of Participants Globally27.9.2020 08:52:00 CESTPress release

Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO), a leading global information technology, consulting and business process services company, today organized the 15th edition of the ‘Spirit of Wipro’ (SOW) Run globally with thousands of participants across 35 countries, running separately, yet together in spirit, at a time of their choosing. The theme for this year’s Run was “United. Unstoppable”, which celebrated camaraderie, resilience and a shared sense of community among several thousands of Wipro employees, their friends and families, alumni, customers, partners and suppliers. The SOW Run is an annual, global tradition at Wipro and has been held every year since its inception. This year too, the Run was organized on schedule despite the pandemic induced constraints. The runners strictly adhered to the local COVID-19 guidelines and safety protocols in various countries while participating in the event. Commenting on the Run, Thierry Delaporte, Chief Executive Officer and Managing

BCG Collaborates with Tencent Marketing Insight to Release 2020 BCG x Tencent Digital Luxury Report25.9.2020 12:21:00 CESTPress release

Since early 2020 when the COVID-19 pandemic broke out worldwide, the luxury market has been hit hard and is expected to decline 25% to 45% compared to the previous year. The Chinese luxury market, however, which has benefitted from successful domestic control of the pandemic and has taken the lead in recovery against a depressed global market environment, is forecast to grow from 20% to 30% in the whole year of 2020. Thanks to its stunning market performance, China has become the main battleground of each major luxury brand. In was in this environment that Boston Consulting Group (BCG) joined hands with Tencent Marketing Insight (TMI) to release the 2020 BCG x Tencent Digital Luxury Report, drawing on deep insights into post COVID-19 trends in the luxury market and consumers based on BCG and TMI’s quantitative consumer research and industry experience, as well as TMI’s marketing and big data capabilities. Crystal Hao, Managing Director & Partner of BCG said, “The luxury market in China

U.S. MRTP Authorization Pathway Explored in PMI’s Latest Scientific Update25.9.2020 12:15:00 CESTPress release

Philip Morris International (PMI) (NYSE: PM) has released the 11th edition of its Scientific Update, a regularly issued publication on its research efforts to develop and scientifically assess a range of smoke-free alternatives to cigarettes. The latest edition features an overview of the historic decision made by the U.S. Food and Drug Administration (FDA) to authorize the marketing of the IQOS Tobacco Heating System with reduced exposure information. The Scientific Update explains the various MRTP decisions under U.S. law; the steps, processes, and timeline PMI undertook; and the ongoing post-market surveillance and studies that will monitor the impact of the orders on consumer perceptions, behavior, and health. “The FDA undertook a scientific and regulatory evaluation of IQOS and determined that it is ‘appropriate for the promotion of public health’” said Dr. Gizelle Baker, director of Global Scientific Engagement at PMI. “In this edition of our Scientific Update, we describe how th

Palladio Completes $20 Million Series B Financing25.9.2020 12:09:00 CESTPress release

Palladio Biosciences, Inc. (Palladio), a privately-held, clinical stage biopharmaceutical company developing medicines for orphan diseases of the kidney, announced today the completion of a $20 million Series B investment. The financing was led by new investor, Samsara BioCapital, with participation from new investor, the Roche Venture Fund and existing investors, Medicxi and Osage University Partners. Proceeds from the financing will fund Palladio’s Phase 3 ALERT Study and advance operations. Srinivas Akkaraju M.D, Ph.D, Managing General Partner of Samsara BioCapital, stated, "We are very excited about our investment in Palladio to support the development of lixivaptan, a drug that has the potential to deliver a meaningful therapeutic advancement in the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD). The ALERT Study is an important step in assessing the safety differential of lixivaptan.” “We are very pleased that Samsara and the Roche Venture Fund recognize the opp

Ant Group Launches “Trusple,” an AntChain-Powered Global Trade and Financial Services Platform for SMEs and Financial Institutions25.9.2020 09:54:00 CESTPress release

Ant Group, a leading provider in the development of open platforms for technology-driven inclusive financial services, and the parent company of China’s largest digital payment platform Alipay, today unveiled Trusple, an international trade and financial service platform powered by AntChain, the company’s blockchain-based technology solutions. Trusple aims to make it easier and less costly for all participants – especially Small-to-Medium Enterprises (SMEs) – to sell their products and services to customers around the world. It also reduces costs for financial institutions so they can better serve SMEs in need. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200925005110/en/ (Photo: Business Wire) Based on the concept of “Trust Made Simple,” Trusple works by generating a smart contract once a buyer and a seller upload a trading order on the platform. As the order is executed, the smart contract is automatically updated with k

Ipsen Appoints Philippe Lopes-Fernandes as Executive Vice President, Chief Business Officer25.9.2020 07:00:00 CESTPress release

Regulatory News: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200924005822/en/ Philippe Lopes-Fernandes, Executive Vice President, Chief Business Officer, Ipsen (Photo: Business Wire) Ipsen (Euronext: IPN; ADR: IPSEY) today announced the appointment of Philippe Lopes-Fernandes as Executive Vice President, Chief Business Officer, effective 1 October 2020. Based in Cambridge, Massachusetts, USA, he will be responsible for business development and alliance management, reporting directly to David Loew, CEO, Ipsen. Philippe will serve on the Executive Leadership Team. “As Chief Business Officer, Philippe will play a crucial role in our external innovation strategy. The ELT and I are delighted to welcome Philippe to Ipsen and look forward to working closely with him. His extensive and impressive track record in international business development, his outstanding reputation and his ability to work closely with the scientific comm

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