INTERCEPT™ Blood System Approved by US FDA

The US Food and Drug Administration (FDA) has approved the INTERCEPT™ Blood System for the ex vivo preparation and storage of platelets and plasma in order to reduce the risk of transfusion-transmitted infection (TTI) and to potentially reduce the risk of transfusion-associated graft versus host disease (TA-GVHD). For platelets, this is the first system of its kind to be available in the United States.

The INTERCEPT Blood System uses a proprietary molecule that, when activated by UVA light, binds to and blocks the replication of DNA and RNA, which are not required for the therapeutic efficacy of platelets or plasma, thereby inactivating a broad spectrum of enveloped viruses, non-enveloped viruses, Gram-positive and Gram-negative bacteria, spirochetes, parasites and leukocytes.

The system offers a valuable proactive alternative to reactive screening tests that require the identification of specific pathogens, especially since pathogens for which there are no available screening tests continue to (re)emerge. Since its introduction in Europe in 2002, over 100 blood centres in 20 countries have replaced these reactive, less exhaustive safety methods with the proactive INTERCEPT Blood System.

Source: "Cerus data on file"