FDA's New Recommendation for Universal Zika Risk Reduction of Blood Components Includes Use of Pathogen Reduction
Cerus Corporation (NASDAQ: CERS) announced today that the U.S. Food and Drug Administration (FDA) has issued a revised guidance document, titled "Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components," which extends its recommendation of appropriate blood safety measures to apply to all U.S. blood centers. Use of pathogen reduction, such as the INTERCEPT Blood System for platelets and plasma, is specified as an acceptable safety measure.
In contrast to the original Zika guidance issued in February, the revised guidance now recommends that Zika risk reduction measures be implemented even outside of areas with active local transmissions (currently Florida and Puerto Rico). For the 11 states considered proximate to the current areas of local transmission or at increased risk for local mosquito-borne cases due to other Zika risk factors (Alabama, Arizona, California, Georgia, Hawaii, Louisiana, Mississippi, New Mexico, New York, South Carolina, and Texas), implementation is required within 4 weeks. All other states have 12 weeks to comply with the revised guidance.
The revised guidance gives U.S. blood centers the choice to either test blood donations with an investigational individual donor nucleic acid test, or implement pathogen reduction technology for platelets or plasma using an FDA-approved pathogen reduction device. The INTERCEPT Blood System for platelets and plasma was approved by the FDA in December 2014, and is already in use by 15 blood centers nationwide, including the American Red Cross. An additional 15 blood centers are under contract, with implementation in progress. A list of INTERCEPT customers in the U.S. is available online at http://intercept-usa.com/implement-intercept/us-customer-list.
"Recent publications have demonstrated likely cases of Zika virus transmission through blood transfusion in Brazil," said Carol Moore, Cerus' senior vice president of regulatory affairs and quality. "With cases of mosquito-borne Zika infections increasing in Florida and the potential for infections to expand into other at-risk states, the FDA's revised guidance demonstrates an increasing level of concern about the threat of transfusion transmission in the U.S. Cerus stands ready to assist blood centers in complying with the FDA's new recommendations."
Pathogen reduction treatment of blood components offers the opportunity for proactive protection against epidemic and endemic pathogens such as Zika, dengue, and chikungunya that may be present in donated blood. Pathogen reduction has also been identified as a measure for reducing the risk of bacterial contamination of platelets to prevent against transfusion-transmitted sepsis.
For the complete FDA guidance document, please visit http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM518213.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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