Cerus Corp. (NSDQ: CERS) said today it won Health Canada approval for its Intercept blood system designed to reduce the risk of transfusion-transmitted infections in blood plasma.
The Concord, Calif.-based company said the system is now cleared in Canada to be used for the ex vivo preparation of pathogen-reduced, whole blood derived or apheresis plasma to reduce the risk of transfusion-transmitted infections.
“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 centers to combat transfusion-transmitted infections,” Cerus regulatory affairs senior veep Carol Moore said in prepared remarks.
The Intercept blood system won approval in the European Union in 2002 and in the U.S. in 2014 and is designed to enhance the safety of donated blood by inactivating a “broad spectrum” of enveloped and non-enveloped viruses, gram-positive and negative bacteria, spirochetes, parasites and potentially harmful white blood cells, Cerus said.
The company said the approval of the Intercept system for plasma will accelerate Health Canada’s review of the system for use with platelets, which the company said will be considered as an amendment to the core license.
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.
In February, Cerus said the American Red Cross inked a multi-year purchase agreement for its Intercept blood system.
The American Red Cross is the largest supplier of blood products in the U.S., collecting and processing approximately 40% of the blood supply, according to Cerus.