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May 5, 2020

Cerus receives FDA approval for new INTERCEPT blood plasma kit

Cerus has received regulatory approval from the US Food and Drug Administration (FDA) for the manufacture of INTERCEPT plasma with a new, alternative plastic disposable kit.

Cerus has received regulatory approval from the US F ood and Drug Administration (F DA) for the manufacture of INTERCEPT plasma with a new, alternative plastic disposable kit.

The conversion to the new kit is in conjunction with the company’s long-existing strategy to advance its global supply chain integrity.

The new system is designed to reduce the risk of transfusion-transmitted infections by a pathogen, reducing a wide range of viruses, bacteria, protozoa and contaminating donor leukocytes in plasma components.

It demonstrates robust inactivation of several members of the coronavirus family, including SARS-1 COV and MERS CoV.

According to the company, the use of the INTERCEPT system in the processing of Covid-19 convalescent plasma cuts down the risk of transfusion-transmitted infections from existing and emerging pathogens and retains antibody titers.

The use of a licensed pathogen technology is required to reduce the risk of transfusion-transmitted infections and alleviate concerns about potential superinfections with SARS-CoV-2, noted the company referring to a published document by the International Society of Blood Transfusion Working Party on Global Blood Safety.

Cerus president and CEO William Greenman said: “The F DA approval for the new INTERCEPT plasma kit is significant as it is a prerequisite for our planned PMA-S submission for pathogen reduced cryoprecipitate, expected this quarter.

“In addition, the approval is important, given the renewed interest in convalescent plasma as a promising treatment for those afflicted with Covid-19.”

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