FDA Approves First Pathogen Reduction System for Plasma

The FDA has approved the first pathogen reduction system for the preparation of plasma by blood establishments.

The Intercept Blood System reduces certain plasma-borne pathogens through a photochemical process involving a controlled exposure to ultraviolet light and amotosalen, a chemical that prevents the replication of DNA and RNA in the pathogens, according to the device manufacturer’s website. Once the pathogens are inactivated, the plasma is purified to remove the amotosalen and its byproducts.

“The approval of devices like the Intercept Blood System allows blood establishments to prepare plasma that carries a lower risk of transmitting infectious pathogens through transfusion,” said Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research, in a press release.

The FDA evaluated plasma prepared using the Intercept Blood System in 8 clinical studies involving a total of 704 patients. The data supporting the use of plasma treated by the Intercept Blood System were obtained from clinical trials conducted in various diseases, including acquired clotting disorders associated with liver disease and thrombotic thrombocytopenic purpura (TTP), a clotting disorder of the blood coagulation system.

The adverse events experienced by patients who received plasma prepared using the Intercept Blood System were comparable to those experienced by participants who received untreated plasma.

While the Intercept Blood System for plasma is effective in reducing a broad variety of viral and bacterial pathogens that may be transmitted through transfusions, including HIV and hepatitis C, no pathogen inactivation process has yet been found to eliminate all pathogens.