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FDA Publishes Final Guidance Document on Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services

Cerus Corporation applauds the publication of the FDA final guidance document titled Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Guidance for Industry. 

The FDA has formally recognized the risk of transfusion transmitted bacterial infections and the need for additional safety measures, including the use of pathogen-reduction technology, to protect patients.

The FDA guidance document published today outlines approaches that blood centers and hospitals will need to implement over the next 18 months to reduce the risk of transfusion transmitted bacterial sepsis.  One approach that offers comprehensive protection against not only bacteria, but also emerging viruses like Zika, is pathogen reduction.  Cerus’ INTERCEPT Blood System is currently the only FDA approved pathogen-reduction technology to treat platelet components.  The INTERCEPT system uses amotosalen, a well characterized photochemical compound that specifically binds to DNA and RNA of bacteria, viruses, and other pathogens, rendering them inactive.  Many of the nation’s largest blood centers and major academic hospitals, including the American Red Cross, have deployed the INTERCEPT system in advance of this final FDA guidance document:

The guidance document can be viewed at the following URL. https://www.fda.gov/media/123448/download

At Cerus, we are proud of our consistent and unwavering focus to secure blood safety around the globe.

Our Mission & Core Values

Cerus will establish INTERCEPT as the standard of care for transfused blood components globally and enable our customers to do everything in their power to deliver safe and effective blood products to patients.

  • The patient is our ultimate concern. We intend to make INTERCEPT the standard of care for blood safety globally.
  • We will be a dependable partner for all blood services to allow them to achieve their important mission, concentrating on ensuring the quality, supply, and operational efficiency of our products. No other company will know blood center operations better, nor provide better service.
  • We operate as one team and resolve to attract and retain the best people in the business. We operate in multiple cultures and geographies and work in a coordinated, mutually supportive fashion.
  • Integrity, perseverance, scientific rigor, and urgency are core to who we are.
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