FDA’s Zika Guidance Document Allows Use of Pathogen Reduction to Reduce Transfusion Risk and Maintain Local Blood Availability

CONCORD, Calif.--(BUSINESS WIRE)-- Cerus Corporation (NASDAQ: CERS) announced today that the U.S. Food and Drug Administration (FDA) has issued a guidance document, titled "Recommendations for Donor Screening, Deferral, and Product Management to Reduce the Risk of Transfusion-Transmission of Zika Virus," which acknowledges the risk of Zika virus (ZIKV) transmission via blood transfusion and identifies appropriate blood safety measures to reduce transfusion risks, including pathogen reduction.

In areas with active local ZIKV transmission via mosquitoes (currently Puerto Rico and the US Virgin Islands), blood centers have the option to either use pathogen reduction to maintain local platelet and plasma collections, or alternatively, to source components from areas without local transmission risk. For blood centers in areas without local ZIKV transmission, donor education and donor deferrals are recommended to reduce the potential risk of ZIKV transmission. Areas of active ZIKV transmission are defined by ongoing CDC reports of autochthonous transmissions (http://www.cdc.gov/zika/geo/index.html), and implementation of the guidance is recommended immediately for pregnant women receiving blood components and within two weeks of the February 17, 2016 issuance date for all others.

“The Zika outbreak, along with recent outbreaks of chikungunya and dengue fever, demonstrate that pathogens continually emerge and present an ongoing threat to public health,” said Carol Moore, Cerus’ senior vice president of regulatory affairs and quality. “The inclusion of pathogen reduction in the FDA’s guidance will allow blood centers in areas directly affected by Zika to take a proactive approach to ensuring the safety of the blood supply sourced from local donors.”

For the complete FDA guidance document, please visit http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM486360.pdf

ABOUT CERUS

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.

View source version on businesswire.com: http://www.businesswire.com/news/home/20160217005869/en/

Cerus Corporation Contacts:
Stacey Leanos - Associate Director, Investor & Public Relations
Lainie Corten - Vice President, Global Marketing & Investor Relations
(925) 288-6137
[email protected]

Source: Cerus Corporation

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