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.
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Source: Cerus Corporation