Cerus, a biomedical products company focused on improving blood transfusion safety, today announced U.S. Food and Drug Administration (FDA) approval of the INTERCEPT Blood System for treatment of platelets suspended in 100% plasma.
This extended label claim further enhances compatibility with commonly used platelet collection methods.
The INTERCEPT Blood System was initially approved by the FDA in December 2014 for treatment of platelets collected in a commercially available platelet additive solution, InterSol.
Use of InterSol is already widespread in Europe; in the U.S., platelet additive solutions have been approved more recently and are still being introduced into blood center and hospital operations.
"This additional approval demonstrates further progress toward optimal collection platform compatibility, as we have had in Europe for a number of years. The label claim expansion will be valuable for blood centers as they consider how to address the revised draft guidance document for bacterial safety standards just issued this week by the FDA, as well as the proposed revised standards set forth in the Code of Federal Regulations," said William ‘Obi’ Greenman, Cerus’ president and chief executive officer.
"A significant number of our customers have been waiting for this approval in order to begin their implementation process for INTERCEPT platelets. We look forward to working with these centers in the coming months to make INTERCEPT platelets more widely available to U.S. hospitals."
Cerus Corporation is a biomedical products company focused in the field of blood transfusion safety. The INTERCEPT Blood System is designed to reduce the risk of transfusion-transmitted infections by inactivating a broad range of pathogens such as viruses, bacteria and parasites that may be present in donated blood.
The nucleic acid targeting mechanism of action of the INTERCEPT treatment is designed to inactivate established transfusion threats, such as Hepatitis B and C, HIV, West Nile Virus and bacteria, as well as emerging pathogens such as chikungunya, malaria and dengue.
Cerus currently markets and sells the INTERCEPT Blood System for both platelets and plasma in the United States, Europe, the Commonwealth of Independent States, the Middle East and selected countries in other regions around the world. The INTERCEPT red blood cell system is in clinical development.
INTERCEPT and INTERCEPT Blood System are trademarks of Cerus Corporation.