CONCORD, Calif.--(BUSINESS WIRE)--
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
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