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Reducing Infectious Risk While Providing Transfusion-Ready Platelets to Patients

Cerus Final Intercept United States 3

Bacterial contamination presents the most significant infectious risk in platelet components,1,2 followed by the emergence of new pathogens such as dengue and chikungunya viruses.3 The INTERCEPT® Blood System enables blood centers and hospitals to comply with recent FDA draft guidance on bacterial contamination,4 and controls risk to patients beyond bacteria with mitigation of TTI due to viruses and parasites, as well as TA-GVHD due to T-cells.5

Recognized as an effective measure to reduce transfusion-transmitted infectious (TTI) risk, pathogen reduction for platelet components provides a holistic solution to blood centers and hospital clients, ultimately benefiting patients who need it most. Not only does pathogen reduction comply with FDA’s pending guidance on addressing bacterial contamination, it reduces risk beyond bacteria with mitigation of TTI due to viruses and parasites, as well as TA-GVHD due to T-Cells. Furthermore, pathogen reduction can be used as an alternative to bacterial testing, CMV testing and gamma irradiation which helps streamline operations.

INTERCEPT Platelets

Enable Blood Centers to:

Enable Hospitals to:
  • Comply with FDA’s pending guidance on minimizing bacterial contamination.4

  • Maintain control of platelet manufacturing unlike secondary bacterial testing measures that are likely to be performed in a hospital setting.6,7

  • Avoid false positive results and associated retesting that can be inherent with testing.

  • Replace bacterial detection, irradiation, CMV testing and Zika virus testing in apheresis platelet components.4,5,6-10
  • Obtain transfusion-ready platelet products that comply with the FDA draft guidance without secondary testing, resulting in minimal operational disruption to hospitals.4

  • Reduce the risk of bacterial contamination and associated sepsis in patients, a cost savings that typically ranges from ~$20K-180K per sepsis case.5,11

  • Reduce infectious risk for patients beyond bacteria, with mitigation of TTI due to viruses and parasites, as well as TA-GVHD due to T-Cells.5

  • Be eligible for CMS reimbursement.12

Blood Matters.™

*Certain non-enveloped viruses (e.g., HAV, HEV, B19 and poliovirus) and Bacillus cereus spores have demonstrated resistance to the INTERCEPT process. 

  1. Kleinman S et al. Transfusion 2013;53:1603-1618. 1.  Kleinman S et al. Transfusion 2013;53:1603-1618.
  2. Benjamin RJ. ISBT Science Series 2014;9:124-130.
  3. Stramer SL, Hollinger FB, et al. Transfusion 2009;49(Suppl 2):1S-29S.
  4. 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, December 2018.
  5. The INTERCEPT Blood System for Platelets Package Insert, Cerus Corporation; July 17, 2018.
  6. AABB/America’s Blood Centers/American Red Cross joint letter to FDA on December 2018 Draft Guidance, Docket No. FDA-2014-D-1814, March 2019.
  7. American Red Cross letter to FDA on December 2018 Draft Guidance, Docket No. FDA-2014-D-1814, February 2019.
  8. “Standards for Blood Banks and Transfusion Services,” AABB, 31st edition, 2018. 
  9. “Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components. FDA Guidance for Industry, July 2018.
  10. “Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis. FDA Guidance for Industry, May 2019.
  11. Definitive Health Care Medicare Database Sepsis Report, 2017.
  12. Centers for Medicare and Medicaid Services (CMS): https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Hospital-Outpatient-Regulations-and-Notices.html.

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