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IN THIS ISSUE
FDA Approves Use of the INTERCEPT Blood System for Platelets Suspended in 100% Plasma Pathogen Reduction Technology Included in FDA's Revised Guidance Document on Bacterial Safety Standards for Platelets Puerto Rico's Largest Blood Bank Adopts INTERCEPT | HHS Responds to Zika Outbreak in Puerto Rico | BCA Selects Cerus as Pathogen Reduction Partner | Science Section: What We're Reading | Calendar of Events
Cerus Receives FDA Approval for Use of the INTERCEPT Blood System for Platelets Suspended in 100% Plasma
Cerus recently announced FDA approval of  the INTERCEPT Blood System for treatment of platelets suspended in 100% plasma, further enhancing compatibility with commonly used platelet collection methods.  The INTERCEPT Blood System was initially approved by the FDA in December 2014 for treatment of platelets collected in a commercially available platelet additive solution, InterSol. “This additional approval demonstrates further progress toward optimal collection platform compatibility, as we have had in Europe for a number of years. The label claim expansion will be valuable for blood centers as they consider how to address the revised draft guidance document for bacterial safety standards just issued this week by the FDA, as well as the proposed revised standards set forth in the Code of Federal Regulations,” said William ‘Obi’ Greenman, Cerus’ president and chief executive officer.

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View the INTERCEPT Blood System for Platelets package insert
Cerus Announces the Inclusion of Pathogen Reduction Technology in FDA's Revised Guidance Document on Bacterial Safety Standards for Platelets
U.S. FDA has issued a revised draft guidance document titled “Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry.”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.

View the FDA guidance
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Banco de Sangre de Servicios Mutuos Signs Agreement for the Use of INTERCEPT Platelets and Plasma
Cerus has recently announced that Puerto Rico's largest blood bank, Banco de Sangre de Servicios Mutuos has signed a purchase agreement for the INTERCEPT Blood System for platelets and plasma to help protect the local blood supply during the Zika outbreak.

"Puerto Rico relies heavily on our local volunteer donation network, which provides the bulk of our blood supply. Utilizing INTERCEPT for platelets and plasma will allow us to continue to do so, as well as alleviate some of the cost burden and additional logistics associated with purchasing blood components from the continental US due to the ZIka guidelines set forth by the FDA," said Jose O. Alsina, vice president of chief operating officer of the blood bank. "INTERCEPT is a critical technology to secure the safety and availability of the Puerto Rican blood supply and ensure safety for patients from transfusion related transmission of Zika virus during this outbreak."

To learn more about Banco de Sangre de Servicios Mutuos please visit donasangrepr.com.
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HHS Ships Blood Products to Puerto Rico in Response to Zika Outbreak
The US Department of Health and Human Services (HHS) has begun shipping whole blood and blood components to Puerto Rico to help maintain a safe and adequate blood supply during the Zika virus (ZIKV) outbreak. Blood collected in the continental US from areas without active ZIKV transmission by the American Red Cross, the Blood Centers of America, and America’s Blood Centers started arriving on the island earlier this month. Additionally, the Administration has submitted a $1.9 billion emergency funding request to Congress to support domestic and international response efforts to ZIKV. Funding requested for the Office of the Assistant Secretary for Preparedness/BioMedical Advanced Research and Development Authority (ASPR/BARDA), FDA, and the NIH will help accelerate the development of blood donor screening tests, additional pathogen reduction technology, as well as potential treatments.

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Blood Centers of America Selects Cerus as its Supply Partner for Pathogen Reduction Technology
Cerus and Blood Centers of America (BCA) have entered into a 5-year agreement with Cerus as a BCA preferred provider. The agreement calls for BCA to actively promote the INTERCEPT Blood System for platelets and plasma to its nearly 50 member blood centers, several of whom have already chosen to adopt INTERCEPT. "The safety of the US blood supply is dependent upon ensuring that we use technology to combat emerging and potentially unknown pathogens that could put patients at risk for transfusion-transmitted infections," said Bill Block, BCA's president and chief executive officer. "We believe that this agreement provides incentives and resources to help make it easier for BCA members to adopt the INTERCEPT Blood System as their new standard in blood transfusion safety." 

BCA is a member-owned organization comprised of independent blood centers throughout North America that account for more than 30% of the US blood supply, distributing over 632,000 platelet and 1,000,000 plasma units to 2,000 hospitals annually.

To learn more about BCA please visit http://bca.coop.

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Science Section: What We’re Reading

Co-distribution and co-infection of chikungunya and dengue viruses
Furuya-Kanmori, L et al. BMC Infectious Diseases. 2016.16:84.
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Constant risk of dengue virus infection by blood transfusion in an endemic area in Mexico

Arellanos-Soto, V et al. Transfusion Medicine. 2015.25:122-4.
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Guillain-Barré Syndrome outbreak associated with Zika virus infection in French Polynesia: a case control study
Cao-Lormeau, VM et al. Lancet. Published online 29 February 2016.
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A Retrospective analysis of false-positive infections screening results in blood donors
Vo, MT et al. Transfusion. 2016;56:457-65.
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Transfusion-transmitted babesiosis during total hip arthroplasty
Carnevale, J et al. Orthopedics. 2015.Sep;38(9):e852-5.
Read the publication (subscription may be required for full access).

 
Calendar of Events

CBBS (California Blood Bank Society) Annual Meeting | Cerus Booth #301
April 6-9, 2016 | San Diego, CA
Additional Information

ASFA (American Society for Apheresis) Annual Meeting
May 4-7, 2016 | Rancho Mirage, CA
Additional Information

CSTM (Canadian Society of Transfusion Medicine) Annual Meeting
May 11-15, 2016 | Vancouver, BC
Additional Information

SCABB (South Central Association of Blood Banks)
June 2-6, 2016 | Houston, TX
Additional Information

ABC Summer Meeting
August 2-4, 2016 | Honolulu, HI
Additional Information

AABB (American Association of Blood Banks) Annual Meeting
October 22-25, 2016 | Orlando, FL
Additional Information
Data for pathogen reduction of ZIKA by the INTERCEPT Blood System, pathogen reduction system, has not been submitted for FDA review.

There is no pathogen inactivation process that has been shown to eliminate all pathogens. Certain non-enveloped viruses (e.g., HAV, HEV, B19 and poliovirus) and Bacillus cereus spores have demonstrated resistance to the INTERCEPT process.

CONTRAINDICATIONS: Contraindicated for preparation of plasma and platelet components intended for patients with a history of hypersensitivity reaction to amotosalen or other psoralens. Contraindicated for preparation of platelet and plasma components intended for neonatal patients treated with phototherapy devices that emit a peak energy wavelength less than 425 nm, or have a lower bound of the emission bandwidth <375 nm, due to the potential for erythema resulting from interaction between ultraviolet light and amotosalen.

WARNINGS and PRECAUTIONS: Only INTERCEPT Processing Sets for platelets and plasma are approved for use with the INTERCEPT Blood System. Use only the INTERCEPT INT100 Illuminator for UVA illumination of amotosalen-treated platelet and plasma components. No other source of UVA light may be used. Please refer to the Operator's Manual for the INT100 Illuminator. Discard any platelet or plasma components not exposed to the complete INT100 illumination process. Tubing components and container ports of the INTERCEPT Blood System contain polyvinyl chloride (PVC). Di(2-ethylhexyl) phthalate (DEHP) is known to be released from PVC medical devices, and increased leaching can occur with extended storage or increased surface area contact. Blood components will be in contact with PVC for a brief period of time (approx. 15 minutes) during processing. The risks associated with DEHP released into the blood components must be weighed against the benefits of therapeutic transfusion.

PLATELETS: INTERCEPT processed platelets may cause the following adverse reaction: Acute Respiratory Distress Syndrome (ARDS). An increased incidence of ARDS was reported in a randomized trial for recipients of INTERCEPT processed platelets, 5/318 (1.6%), compared to recipients of conventional platelet components (0/327). Monitor patients for signs and symptoms of ARDS.


PLASMA: Amotosalen-treated plasma may cause the following adverse reaction Cardiac Events. In a randomized controlled trial of therapeutic plasma exchange (TPE) for TTP, five patients treated with INTERCEPT Blood System processed plasma and none with conventional plasma had adverse events in the cardiac system organ class (SOC) reported. These events included angina pectoris (n=3), cardiac arrest (n=1), bradycardia (n=1), tachycardia (n=1) and sinus arrhythmia (n=1). None of these events resulted in documented myocardial infarction or death. Monitor patients for signs and symptoms of cardiac events during TPE for TTP.

Rx only. For full prescribing information, please see package insert.
MKT-EN 00165-09
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Cerus, INTERCEPT Blood System and INTERCEPT are registered trademarks of Cerus Corporation.

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