The company’s conversion to the new disposable kit represents its strategy to enhance its global supply chain’s integrity, according to a news release. The approval is a prerequisite for the company’s planned PMA-S submission for pathogen-reduced cryoprecipitate, which Cerus expects this quarter.
Concord, Calif.-based Cerus designed the Intercept blood system to pathogen reduce viruses, bacteria, protozoa and contaminating donor leukocytes in plasma components. Once used, the system reduces the risk of transfusion-transmitted infections.
A recent paper published by the International Society of Blood Transfusion Working Party on Global Blood Safety indicated that the use of a licensed pathogen technology is desirable in reducing the risk of transfusion-transmitted infections that could include SARS-CoV-2, the virus causing coronavirus. According to Cerus’ release, the Intercept system demonstrated success with several members of the COVID-19 family, including SARS-1-COV and MERS CoV.
“The approval is important given the renewed interest in convalescent plasma as a promising treatment for those afflicted with COVID-19,” Cerus president & CEO William Greenman said in the release. “The use of the Intercept system in the processing of COVID-19 convalescent plasma reduces the risk of transfusion-transmitted infections from known and emerging pathogens and retains antibody titers.”