CONCORD, Calif.–(BUSINESS WIRE)–Cerus Corporation (Nasdaq:CERS) announced today the issuance of a new
U.S. Food and Drug Administration (FDA) draft guidance document on
bacterial risk control strategies for platelet collection and
transfusion. Cerus supports the FDA’s efforts to enhance the safety of
the U.S. platelet supply, including recommendations for use of approved
pathogen reduction technologies such as the INTERCEPT Blood System.
“Bacterial contamination of platelets is a risk faced by transfusion
patients everyday with a rate as high as 1 in 1,500 units. With patients
typically receiving multiple units of platelets, the risk of receiving a
potentially contaminated unit is even greater,” said William ‘Obi’
Greenman, Cerus’ president and chief executive officer.
“This long-anticipated draft guidance document issued today by the FDA
provides a framework of options, including the use of pathogen
reduction, which the FDA acknowledges controls the risk of bacterial
contamination of platelets,” continued Greenman.
Interested parties have 60-days to comment on the draft guidance
document after which the FDA will begin work on the final version of the
guidance document. Once finalized, the FDA recommends blood centers and
hospitals implement the recommended guidelines within 12 months.
The document can be viewed on the FDA website at the following URL: https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM627407.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 http://www.cerus.com
for information about Cerus.
INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus