FDA Approves System to Reduce Pathogens in Donated Blood Plasma

FDA: New System Targets Pathogens in Donated Blood Plasma
FDA: New System Targets Pathogens in Donated Blood Plasma

(HealthDay News) -- A new system designed to reduce pathogens in donated blood plasma and reduce the risk of transfusion-transmitted infections has been approved by the U.S. Food and Drug Administration.

The Intercept Blood System for plasma targets pathogens such as AIDS-causing HIV, hepatitis B and C, and the West Nile virus, the FDA said in a news release. The system uses controlled exposure to ultraviolet light and amotosalen. The plasma is then purified to remove the chemical and any byproducts.

While the system has proven effective, no system or device has been shown to eliminate all pathogens. The Intercept system hasn't been effective, for example, in eliminating the human parvovirus B19 and spores formed by certain bacteria, the FDA said.

The system's clinical safety and effectiveness were evaluated in studies involving more than 700 people. Side effects were comparable to those among people who received untreated plasma, the agency said.

The Intercept system is marketed by Cerus Corp., based in Concord, Calif.

Source

  1. FDA news release, December 16, 2014
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