CONCORD, Calif.--(BUSINESS WIRE)--
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Drug Administration (FDA) has issued a revised draft guidance document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Availability of Platelets for Transfusion; Draft Guidance for Industry.”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Under the requirements specified in the draft guidance, platelet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.
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