New System to Make Donor Blood Safe

A new pathogen inactivation system for donor blood is positioned to be the first such system to be offered in Europe, now that the disposable set for inactivating pathogens in platelets has received the CE Mark.

Called Intercept, the system comprises a pathogen inactivation system consisting of a disposable set containing a light-activated, nucleic acid-targeting compound and an illumination device. No further regulatory agency review is expected for the illumination device. Intercept uses a light-activated compound called Helinx. When activated, Helinx binds to and crosslinks nucleic acids (DNA and RNA) in viruses, bacteria, and other pathogens, rendering them unable to multiply. The compound also prevents the proliferation of white blood cells, associated with a variety of adverse transfusion reactions.

Following light exposure, the by-products of the pathogen inactivation process are removed and the Intercept platelets are transferred to a bag where they are stored under normal platelet storage conditions until transfusion. Mature platelets, plasma, and red blood cells do not contain DNA or RNA and therefore are not targeted by the Intercept process.

The commercialization of the system follows more than a decade of collaboration between Cerus Corp. (Concord, CA, USA) and Baxter International, Inc. (Deerfield, IL, USA; www.baxter.com). The two companies say they are the only ones in clinical trials and undergoing regulatory review for pathogen inactivation systems for all three of the primary blood components: platelets, plasma, and red blood cells.




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Cerus
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