Policy & Regulation
GenScript files for FDA's EUA for rapid SARS-CoV-2 neutralization antibody detection kit
4 June 2020 -

Research reagent provider GenScript Biotech Corp said on Wednesday that it has submitted an Emergency Use Authorization (EUA) filing with the US Food and Drug Administration (FDA) to market its cPass SARS-CoV-2 Neutralization Antibody Detection Kit.

According to GenScript its new test is the first 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.

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 has received CE marking for commercial use as an in vitro diagnostic product in Europe.



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