GenScript Files for Emergency Use Authorization of Rapid SARS-CoV-2 Neutralization Antibody Detection Kit

GenScript Biotech Corp., the world's leading research reagent provider, announced today that the company has filed for Emergency Use Authorization (EUA) with the U.S. Food and Drug Administration (FDA) to market its cPass™ SARS-CoV-2 Neutralization Antibody Detection Kit. This is the first test submitted for regulatory approval that specifically detects neutralizing antibodies to SARS-CoV-2, the virus that causes COV-19, without the use of live virus. Current serological antibody tests identify prior exposure to the virus by detecting the presence of antibodies from an immune response, but do not indicate whether these antibodies are neutralizing antibodies. A virus neutralization test detects the presence of neutralizing antibodies, which are key biomarkers of immunity and act to protect the body by blocking the virus's entry into the cell. Traditional virus neutralization tests require live virus and cells and must be performed in a biosafety containment facility staffed by highly skilled personnel, with results often taking days. The cPass kit enables detection of neutralizing antibodies within an hour, without the need for live virus and biosafety containment, making it broadly available to standard labs in hospitals and clinics. The kit, which is compatible with both manual, automated and high-throughput immunoassay workflows such as ELISA, has received CE marking for commercial use as an in vitro diagnostic product in Europe.

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