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The FDA Approves Cerus’s Intercept System for Platelets and Plasma

January 7, 2015

107254194The FDA recently approved the Cerus Corporation’s Intercept Blood System for platelets and plasma which has been used in Europe since 2002. The Intercept system inactivates a broad spectrum of pathogens and T cells, lowering the risk of transfusion-transmitted infections and transfusion-associated graft-versus-host disease.

The Intercept system uses the chemical amotosalen which binds DNA and RNA and inhibits replication of many bacteria, viruses, parasites and white blood cells. Platelets, plasma and red blood cells do not require functional nucleic acids for transfusion efficacy. Although non-enveloped viruses and bacteria spores are not affected by the Intercept system, this proactive approach will help maintain a safer blood supply by deactivating newly emerging pathogens without available screening tests such as chikungunya and Ebola.

References
1. FDA News Release. FDA approves first pathogen reduction system to treat plasma, December 16, 2014. Accessed online January 7, 2015. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm427111.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
2. FDA News Release. FDA approves pathogen reduction system to treat platelets, December 19, 2014. Accessed online January 7, 2015. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm427500.htm
3. The Intercept Blood System for Platelets and Plasma, December 18, 2014. Access online January 7, 2015. http://www.intercept-usa.com/

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  • Policy and Guidelines
  • Transfusion Transmitted Infections

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