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FDA approves plasma pathogen reduction system
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The FDA has approved the first pathogen reduction system for use in plasma preparation, according to a press release.
The Intercept Blood System (Cerus Corp.) for plasma can be used by blood establishments to reduce the prevalence of HIV, hepatitis B and C viruses, West Nile virus and other pathogens transmitted in plasma obtained by apheresis. The system uses a photochemical process involving controlled exposure to ultraviolet light and amotosalen, a chemical that renders the pathogen inactive. The plasma is then purified to remove amotosalen and its byproducts before use.
“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,” Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release.
Karen Midthun
Plasma prepared using the system was evaluated in eight clinical studies of 704 patients from multiple settings. Adverse events experienced by those who did or did not use the system were comparable, but certain viruses and bacterial spores are known to be resistant to the process.