FDA OKs Pathogen Reduction System to Treat Platelets
First pathogen reduction system to treat single-donor apheresis platelets
FRIDAY, Dec. 19, 2014 (HealthDay News) -- A new system designed to remove viruses, bacteria, and other pathogens from donated blood platelets was approved Friday by the U.S. Food and Drug Administration. Earlier in the week, the agency approved a similar system to remove pathogens from donated blood plasma.
The Intercept Blood System can filter platelets of AIDS-causing HIV, hepatitis B and C, and West Nile virus, the FDA said in a news release. However, the system does not remove all pathogens, having been shown ineffective in removing human parvovirus B19 and spores formed by certain bacteria, the agency added.
Platelets prepared using the Intercept system were determined to be safe and effective in 10 clinical studies involving 844 people, the FDA said.
"The Intercept Blood System for platelets represents an important advancement in improving platelet safety, both in reducing the risk of contamination with bacteria and other pathogens and in lowering the risk of transfusion-associated graft-versus-host disease," Karen Midthun, M.D., director of the FDA's Center for Biologics Evaluation and Research, said in the news release.
The system is marketed by Cerus Corp., based in Concord, Calif.