Health Canada has granted approval for Cerus' Intercept Blood System for ex-vivo preparation of pathogen-reduced, whole blood derived or apheresis plasma.
Approved in Europe and the US since 2002 and 2014, respectively, the Intercept Blood System increases the safety and efficacy of donated blood components by neutralising a wide range of enveloped and non-enveloped virus, Gram-positive and Gram-negative bacteria, spirochetes, and parasites, as well as harmful white blood cells inherent in the blood of the donor.
Platelets, plasma and red blood cells do not require functional DNA or RNA for therapeutic efficacy while pathogens like bacteria, viruses, parasites and white blood cells require the DNA and RNA to replicate into the guest.
This basic biological difference between the therapeutic components of blood, compared to harmful pathogens and donor white blood cells is targeted by the Intercept Blood System which activates its patented molecule binding to the nucleic acids, preventing nucleic acid replication and subsequently neutralising the pathogen, hence reducing the risk of transfusion-transmitted infection (TTI).
Cerus regulatory affairs and quality senior vice-president Carol Moore said: "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.
"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 centres to combat transfusion-transmitted infections."
The approval of the Intercept Blood System for plasma will aid Health Canada's review of the system for platelets, which will introduce an amendment to the core license.