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Cerus Corporation Applauds FDA Requirements Effective Today to Safeguard the U.S. Platelet Supply
CONCORD, Calif.--(BUSINESS WIRE)-- Today marks the effective date for the U.S. Food and Drug Administration’s (FDA) final guidance document on bacterial risk
About this update from Cerus Corporation
[{"type":"text","content":" CONCORD, Calif.--(BUSINESS WIRE)--\nToday marks the effective date for the U.S. Food and Drug Administration’s (FDA) final guidance document on bacterial risk control strategies for platelet collection and transfusion. This guidance for industry, “Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelet for Transfusion,” which was finalized in 2020, identifies FDA-approved pathogen reduction as a means of compliance and, as such, provides a way to protect the U.S. platelet supply from bacterial contamination using the INTERCEPT Blood System for platelets. Cerus Corporation’s (Nasdaq: CERS) INTERCEPT Blood System for platelets also reduces risk beyond bacteria, inactivating a broad range of viruses and parasites, as well as the white blood cells that can cause transfusion-associated graft-versus-host disease.\n\n“The steps called for by the FDA guidance mark a significant milestone for the field of transfusion medicine, the safety of platelet transfusions, and the health of patients across the country,” said Dr. Laurence Corash, Cerus’ chief scientific officer and co-founder. “Bacterial contamination in platelets has been recognized as the greatest transfusion-transmission infectious risk in the United States.1 Transfusing a contaminated unit can cause numerous issues for transfusion recipients, including transfusion-transmitted infection that can lead to severe adverse outcomes for these patients.”\n\n“As blood centers and their hospital customers have been working tirelessly to choose and deploy measures that will ensure compliance with the new FDA guidance, we have been working alongside these customers with the goal of making the INTERCEPT Blood System for platelets the standard of care in the U.S. market. I am pleased that patients across the U.S. will have an additional layer of safety, enabled by our platform,” continued Corash.\n\nFor two decades, the INTERCEPT Blood System for platelets and plasma has been used around the world to help safeguard the supply of platelets and plasma. Today, Cerus’ INTERCEPT Blood System for platelets is the only FDA-approved pathogen reduction measure currently available in the U.S. for compliance with the FDA guidance.\n\n\nCenters for Disease Control and Prevention: https://www.cdc.gov/bloodsafety/bb...