Cerus Corp. (NSDQ:CERS) announced today that it received FDA approval for its Intercept plasma with an alternative plastic disposable kit.
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.”
