First Pathogen Reduction System to Prep Plasma, Platelets for Transfusion Approved
The Food and Drug Administration (FDA) has approved Cerus' Intercept Blood System for plasma and platelets, the first pathogen reduction system to use in preparation of plasma and platelets in order to reduce the risk of transfusion-transmitted infections (TTI).
The Intercept Blood System can be used in plasma and platelets derived from whole blood from apheresis. Pathogens such as HIV, hepatitis B and C, and the West Nile virus may be reduced through use of the Intercept Blood System. Some viruses (eg, human parvovirus B19) and certain spores are known to be resistant to the Intercept Blood System process.
The System works via a photochemical process that involves controlled exposure to ultraviolet light and the chemical amotosalen. The plasma or platelet sample is then purified to remove the chemical and its byproducts. The use of plasma treated by the Intercept Blood System was assessed in eight clinical studies consisting of 704 patients in different clinical settings such as acquired clotting disorders associated with liver disease and thrombotic thrombocytopenic purpura (TTP).The use of platelets was assessed in 10 clinical studies of 844 patients,
For more information visit FDA.gov.