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Health Canada approves blood system for platelets


 

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Platelets for transfusion

Health Canada has approved commercialization of the INTERCEPT Blood System for platelets, which is used for the ex vivo treatment and storage of platelet components.

The INTERCEPT Blood System for platelets can inactivate a range of pathogens—including viruses, bacteria, and protozoan parasites—to reduce the risk of transfusion-transmitted infections.

The system also inactivates contaminating donor leukocytes to reduce the risk of transfusion-associated graft-versus-host disease.

“[The INTERCEPT Blood System for platelets] provides an important, proactive safety measure to reduce the risk of transfusion-transmitted infections from known and emerging pathogens,” said Carol Moore, of Cerus Corporation, the company marketing the system.

“The approval provides blood centers the flexibility to pathogen-inactivate platelets derived from whole blood or apheresis collections, and stored in either platelet additive solution or plasma. In addition, Canadian blood centers will be able to create larger platelet pools from whole blood collections and use our double-dose INTERCEPT kits to yield 2 therapeutic platelet doses to realize improved operational efficiencies and economics.”

The INTERCEPT Blood System for platelets is Cerus Corporation’s second pathogen-inactivated system to be approved in Canada. The INTERCEPT Blood System for plasma was approved in May 2016.

The platelet and plasma systems use the same illumination device, the same active compound (amotosalen), and very similar production steps.

The INTERCEPT systems target a basic biological difference between the therapeutic components of blood. Platelets, plasma, and red blood cells do not require functional DNA or RNA for therapeutic efficacy. But pathogens and white blood cells do, in order to transmit infection.

The INTERCEPT systems use a proprietary molecule (amotosalen) that, when activated by UVA light, binds to and blocks the replication of DNA and RNA, preventing nucleic acid replication and rendering the pathogen inactive.

The INTERCEPT Blood System for platelets has been approved in Europe since 2002 and in the US since 2014.

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