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Singapore's EUA certified cPass(TM) SARS-CoV-2 Neutralization Ab kit detects Abs in 1hr

13 November 2020 | News

First antibody detection kit to receives EUA authorization along with CE-IVD, FDA approval (Philippines) and HSA authorization (Singapore)

Photo Credit: GenScript

Photo Credit: GenScript

GenScript Biotech Corporation's cPass™ SARS-CoV-2 Neutralization Antibody Detection Kit has received provisional authorization by Health Science Authority (HSA) Singapore on 8th May 2020, CE-IVD marking in Europe on 26th May 2020 and FDA approval in Philippines for commercial use on 11th August 2020.

Adding to these, U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for cPass™ SARS-CoV-2 Neutralization Antibody Detection Kit on 6th November 2020.

cPass™ SARS-CoV-2 Neutralization Antibody Detection Kit which is co- developed with Duke-NUS Medical School Singapore and Diagnostics Development Hub from Singapore's Agency for Science, Technology and Research (A*STAR) and manufactured by GenScript Biotech Corporation, is the first serology test authorized to detect neutralizing antibodies – the specific antibodies present in the serum of COVID-19 patients that are responsible for clearing the viral infection, without the need of live biological materials and biocontainment facility. The test measures the presence of neutralizing antibodies in patients recovering from COVID-19 or receiving a vaccine.

GenScript has started to serve global market through authorized distributors and authorized laboratories to provide the test to public. GenScript promised to support the healthcare community and continue the fight against COVID-19.

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