GenScript's SARS-CoV-2 Neutralizing Antibody Detection Kit Receives European Approval for Direct-to-Consumer Sale

GenScript's latest at-home rapid test is designed to help individuals make better health decisions regarding SARS-CoV-2 exposure; it detects neutralizing antibodies in patients who have either been infected with COVID-19 or vaccinated against the disease

RISJSWIJK, Netherlands, July 12, 2022 /PRNewswire/ -- GenScript Biotech (Netherlands) BV, a subsidiary of GenScript Biotech Corporation ("GenScript", Stock Code: 1548.HK), a world-leading biotechnology company, announced that its SARS-CoV-2 Neutralizing Antibody Detection Kit is now available for sale, direct to consumers, across the European Union. The kit has European approval for CE OTC.

This at-home test detects neutralizing antibodies (nAbs) in patients recovering from or vaccinated against COVID-19. Within 15 minutes of taking the test, an individual will know if they have virus-blocking nAbs. This information may be useful for individuals who may need to take extra precautions against SARS-CoV-2 or for healthy people who want to spend time with at-risk individuals who may have acquired very low immunity to the virus.

GenScript's SARS-CoV-2 Neutralizing Antibody Detection Kit uses novel technology to detect antibodies specific to the spike protein receptor binding domain (S-RBD) of the SARS-CoV-2 virus responsible for COVID-19. Antibodies to this specific antigen are generated by the body via two methods: 1) natural infection or 2) vaccination. The S-RBD is the critical viral component used by the virus to enter human cells and is the primary target used in vaccine development to elicit a specific immune response.

Detecting the presence of the neutralizing antibodies is the first step in determining whether there is an adaptive immune response for an individual, and therefore their relative level of risk of infection (or reinfection). In the elderly, nAbs levels decline faster, and potentially an immuno-comprised person did not generate sufficient immune response in the first place. Therefore, knowing whether an individual currently has a detectable adaptive immune response helps us make better health decisions to protect them.

"As we enter the endemic phase of COVID-19, doctors and patients need more tools to understand their risks of infection and to calibrate their behaviors and responses. Increasingly, it will be more important to understand a person's protection against COVID-19 vs. testing for infection," said Dr. Michael Lau, senior director of corporate development for GenScript USA. "We are pleased to now offer an at-home test that can accurately detect an individual's immune-response to SARS-CoV-2."

Note: the test is not a COVID-19 antigen lateral-flow test; it does not inform whether an individual is currently infected with SARS-CoV-2.

GenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Based on its leading gene synthesis technology, GenScript has developed four major platforms including the global cell therapy platform, the biologics contract development and manufacturing organization (CDMO) platform, the contract research organization (CRO) platform, and the industrial synthesis product platform. The company's operations span over 100 countries and regions worldwide with legal entities located in the USA, Mainland China, Hong Kong, China, Japan, Singapore, the Netherlands, and Ireland. GenScript provides premium, convenient, and reliable products and services for over 100,000 customers. For more information, please visit genscript.com.

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