Cerus Supports FDA’s Continuing Efforts to Enhance the Safety of the U.S. Platelet Supply
CONCORD, Calif.--(BUSINESS WIRE)--Dec 4, 2018--Cerus Corporation (Nasdaq:CERS) announced today the issuance of a new U.S. Food and Drug Administration (FDA) draft guidance document on bacterial risk control strategies for platelet collection and transfusion.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“This long-anticipated draft guidance document issued today by the FDA provides a framework of options, including the use of pathogen reduction, which the FDA acknowledges controls the risk of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Interested parties have 60-days to comment on the draft guidance document after which the FDA will begin work on the final version of the guidance document.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 Corporation.
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KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA
INDUSTRY KEYWORD: SURGERY HEALTH BIOTECHNOLOGY CARDIOLOGY HOSPITALS MEDICAL DEVICES FDA
SOURCE: Cerus Corporation
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PUB: 12/04/2018 05:00 PM/DISC: 12/04/2018 05:01 PM