Cerus Corporation, a biomedical products company, announced that Health Canada has approved the Intercept Blood System for plasma. The Intercept Blood System for plasma is intended to be used for the ex vivo preparation of pathogen-reduced, whole blood derived or apheresis plasma in order to reduce the risk of transfusion-transmitted infection (TTI).
The Intercept Blood System has been approved for use in Europe since 2002 and in the United States since 2014. It is designed to enhance the safety of donated blood components by inactivating a broad spectrum of enveloped viruses, non-enveloped viruses, Gram-positive and Gram-negative bacteria, spirochetes, and parasites, as well as potentially harmful white blood cells present in donor blood.
“While current screening tests have lowered the risks from transfusion-transmitted infections, these tests are reactive approaches only covering a small number of pathogens that pose a risk to the blood supply," said Carol Moore, SVP, regulatory affairs and quality at Cerus. “Over 300,000 units of plasma are used in transfusion annually in Canada. Health Canada’s approval of the Intercept Blood System now provides an important proactive safety measure for Canadian blood centers to combat transfusion-transmitted infections.”
Platelets, plasma and red blood cells do not require functional DNA or RNA for therapeutic efficacy. However, pathogens (bacteria, viruses and parasites) and white blood cells do require these nucleic acids in order to replicate. The Intercept Blood System targets this basic biological difference between the therapeutic components of blood, compared to harmful pathogens and donor white blood cells. The system uses a proprietary molecule that when activated, binds to DNA and RNA, preventing nucleic acid replication and rendering the pathogen inactive.
Approval of the Intercept Blood System for plasma also helps move forward Health Canada’s review of the Intercept Blood System for platelets, which will be considered an amendment to the core license.
The Intercept Blood System for plasma is intended to be used for the ex vivo preparation of pathogen-reduced, whole blood derived or apheresis plasma in order to reduce the risk of transfusion-transmitted infection (TTI).
The safety and efficacy of plasma prepared with the Intercept Blood System has been evaluated in eight clinical studies including a total of over 600 patients requiring plasma transfusions. Intercept plasma has been monitored and shown to be safe in routine use through hemovigilance programmes covering over 200,000 Intercept-processed plasma components.