- New Label Claim Expands the Market for Cerus' INTERCEPT Blood System in the United States--Cerus Corporation (NASDAQ:CERS) announced today that the U.S. Food and Drug Administration (FDA) has issued a revised draft guidance document titled “Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry.” The document is intended to provide blood centers with recommendations for controlling the risk of bacterial contamination of platelets, and pathogen reduction technology is included as a recommended method to reduce the risk of transfusion-transmitted sepsis.
“The risk of bacterial contamination in platelet units is higher than other blood components due to their need to be stored at room temperature. Despite screening interventions, recent active surveillance studies have shown that bacterially contaminated platelet transfusions continue to occur at a rate as high as 1 in 1,000,” commented Dr. Richard Benjamin, chief medical officer of Cerus. “By revising the bacterial safety standards, the FDA has made a strong statement that there is a need to do more to protect patients from septic transfusion reactions.”
Under the requirements specified in the draft guidance, platelet components must either be tested for bacteria, or undergo treatment via pathogen reduction technology. If testing is used to ensure bacterial safety, it must include both an early culture test at >24 hours following collection, as well as a secondary test for any platelet unit stored for four or five days. If pathogen reduction is used, no preventive testing steps are required during this period. The INTERCEPT Blood System is currently the only FDA-approved pathogen reduction technology.
“Inclusion of a pathogen reduction option lets blood centers eliminate the early bacterial culture test, allowing for release of platelet components to hospitals sooner,” said Carol Moore, Cerus’ senior vice president of regulatory affairs and quality. “In addition, it allows hospitals to avoid changing their operating procedures to include secondary testing.”
The complete FDA guidance is available on the FDA’s website - http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM425952.pdf.
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. See www.cerus.com for more information about Cerus.
INTERCEPT and INTERCEPT Blood System are trademarks of Cerus Corporation.
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