Cerus : FDA Oks Pathogen Reduction System To Treat Plasma

(RTTNews) - The U.S. Food and Drug Administration approved the Intercept Blood System for plasma, the first pathogen reduction system for use by blood establishments in the preparation of plasma in order to reduce the risk of transfusion-transmitted infections or TTI. The Intercept Blood System for plasma is marketed by Cerus Corporation, Concord, California.

The Intercept Blood System for plasma may be used to reduce pathogens in plasma derived from whole blood and plasma obtained by apheresis, a collection process that separates red blood cells from plasma and then returns the red cells to the donor.

The inactivation of certain potential pathogens in plasma treated using the Intercept Blood System is achieved through a photochemical process involving a controlled exposure to ultraviolet light and amotosalen, a chemical that facilitates the inactivation process. The plasma is then purified to remove the chemical and its byproducts.

While the Intercept Blood System for plasma has been shown to be effective in reducing a broad range of viral and bacterial pathogens that may be transmitted through transfusions, there is no pathogen inactivation process that has been shown to eliminate all pathogens. Certain viruses (e.g. human parvovirus B19) and spores formed by certain bacteria are known to be resistant to the Intercept process.

The adverse events experienced by patients who received plasma prepared using the Intercept Blood System for plasma were comparable to those experienced by participants who received plasma that had not been treated with the pathogen reduction device.