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GenScript Receives FDA Emergency Use Authorization for Use of cPass(TM) SARS-CoV-2 Neutralization Antibody Test in Convalescent Plasma Screening

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PISCATAWAY, N.J., Feb. 11, 2021 /PRNewswire/ GenScript USA Inc., the world s leading life science research tools and services provider,
announced today that it has received Emergency Use Authorization by the U.S. Food and Drug Administration s Center for Biologics Evaluation and Research (CBER) for use of the cPass™ SARS-CoV-2 Neutralization Antibody Detection Kit in convalescent plasma screening. The cPass kit is the first FDA authorized test that specifically detects COVID-19 neutralizing antibodies without the use of live virus. Neutralizing antibodies block the ability of the virus to infect a cell and are widely recognized biomarkers of immunity. ....

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GenScript Submits Application with FDA for Use of cPass™ SARS-CoV-2 Neutralization Antibody Test in Convalescent Plasma Screening

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PISCATAWAY, N.J., Jan. 13, 2021 /PRNewswire/ GenScript USA Inc., the world s leading research reagent provider, announced today that it has submitted an application to the U.S. Food and Drug Administration s Center for Biologics Evaluation and Research (CBER) for use of the cPass™ SARS-CoV-2 Neutralization Antibody Detection Kit in convalescent plasma screening. The kit, which has been authorized by the FDA for emergency use in clinical diagnostics laboratories, is the first commercially available product to specifically detect COVID-19 neutralizing antibodies without the use of live virus. Neutralizing antibodies block the ability of the virus to infect a cell and are widely recognized biomarkers of immunity. ....

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