Update on pathogen reduction technology

Abstract

BackgroundThe development and adoption of pathogen reduction technology (PRT) continues. The ability to reduce transmission of a broad range of infectious and non‐infectious threats remains the primary reason PRT is attractive.AimThe objective of this update is to review recent findings in the development of the three most widely available PRT methods for labile blood components.MethodsThe update uses important recent publications to bring to attention new findings, current clinical studies being conducted and data from routine use in countries where regulatory approval has been obtained.ResultsTerumoBCT Mirasol™ – Recent clinical research on Mirasol‐treated platelets and plasma PRT has focused on studies that quantify the performance of white blood cell inactivation, with strong evidence of advantages over gamma irradiation. Published research on whole blood PRT currently in development provides evidence of pathogen reduction, white cell inactivation and reduction in antigen expression. Mirasol‐treated platelets are in routine use in 18 countries and plasma in routine use in 11 countries.Macopharma Theraflex™ – Initial success in developing a novel procedure that uses short‐wave ultraviolet light (UVC) without addition of a photoactive chemical to treat platelets has been reported and is currently being evaluated for safety and efficacy. Based on haemovigilance data for methylene blue (MB)‐treated plasma, a significantly higher incidence of severe allergic reactions or other adverse events in comparison with other fresh frozen plasma types could not be confirmed. Theraflex MB‐treated plasma is in routine use in 15 countries.Cerus Intercept™ – Efforts to understand the impact of Intercept‐treated platelets based on proteomic analyses have been reported, and the overall interpretation of proteomic findings is that although some minor changes are evident, there is no indication or evidence for a potential clinical concern for transfusion recipients. Other areas of active research focus on the inactivation of RBC concentrates using the second generation treatment process with S‐303. Intercept‐treated platelets are in routine use in 21 countries and plasma in routine use in 12 countries.ConclusionBoth controlled clinical studies and post‐marketing surveillance are necessary to further establish the safety and effectiveness of each PRT method. Recent evidence does not suggest an obvious safety threat for any of the current PRT methods in routine use. The relative value in terms of patient health and health economics, including cost‐utility, of these methods in terms of health gains achieved by PRT remain insufficiently studied.