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In this Issue
NIH Enters Into Agreement for the Use of INTERCEPT® Platelets and Plasma | Blood Banks Leading the Way with the Adoption of Pathogen-Reduction
| AABB Symposium on the Implementation of Pathogen-Reduced Blood in the US | New England Journal of Medicine Article Calls for FDA to Mandate Pathogen Reduction New 7-Year Haemovigilance Study Describes Routine Use INTERCEPT® Platelets | Recent Article Explores the Financial Impact of Implementing Pathogen Reduction | Calendar of Events

NIH Enters Into Agreement for the Use of INTERCEPT® Blood System for Platelets and Plasma, Pathogen Reduction System
Cerus Corporation and the National Institutes of Health (NIH) have announced a three-year purchase agreement for the INTERCEPT Blood System for Platelets and Plasma. As part of the United States (US) Department of Health and Human Services, the NIH is the primary federal agency conducting and supporting medical research for common and rare diseases. The NIH institutes and centers include the NIH Clinical Center, the largest hospital in the world, dedicated to clinical research. Approximately 9,000 platelet and 15,000 plasma components are collected and transfused annually, for the NIH Clinical Center in Bethesda, Maryland.
Blood Banks Leading the Way with the Adoption of Pathogen-Reduction
Cerus Corporation has recently announced they have signed three-year purchase agreements for the INTERCEPT Blood System for Platelets and Plasma with the Blood Bank of Delmarva (BBD) and SunCoast Blood Bank (SCBB).  BBD provides blood transfusion products and services to hospitals in Delaware, Cecil County, Maryland, as well as the Eastern Shores of Maryland and Virginia totaling approximately 13,000 platelet and 21,000 plasma units per year. SCBB collects over 45,000 units of blood products, including 6,000 units of platelets and over 5,500 plasma units per year, to support 12 hospitals in the area.
“The choice for us to partner with Cerus was easy. If there is a product on the market that dramatically reduces the transmission of pathogens and parasites, then we owe it to our patients and our community to provide it,” said Scott Bush, chief executive officer of SCBB. “We are very excited to become the first blood center in Florida to offer INTERCEPT-treated components, to mitigate transfusion related incidents. SunCoast Blood Bank has a commitment to serving our community through forward thinking and innovative technologies supporting our primary mission, squarely focusing on the health and welfare of our patients.”
Interested in learning more about implementing pathogen reduction at your center?
Please click here to visit www.INTERCEPT-USA.com.
AABB Symposium on the Implementation of Pathogen-Reduced Blood in the US
Recent FDA approvals of the first platelet and plasma pathogen reduction system prompted an AABB symposium on the implementation of pathogen reduction technology in the US. Representatives from US and International blood centers, healthcare providers, industry, and the FDA gathered in late April to discuss numerous topics surrounding the current science, efficacy, cost, and legal implications of adopting pathogen reduction at blood centers and transfusion services.

Though the financial implications related to pathogen reduction remain a concern for blood centers and hospitals, the benefits of a proactive approach to improving the safety of the blood supply with pathogen reduction were expressed by a number of speakers. Benefits were particularly highlighted as they relate to the mitigation of emerging pathogens, as well as the need to address bacterial contamination risk through logistically less complex means when compared to existing bacterial detection methods.

For more information or to purchase the sync-to-slide presentation, please visit the AABB Marketplace by clicking here.
New England Journal of Medicine Article Calls for FDA to Mandate Pathogen Reduction
With the FDA’s recent approval of pathogen reduction, the reactive approach of pathogen-specific testing is no longer sufficient to protect the safety of our blood supply. As blood centers begin to navigate this paradigm shift the authors call on the federal government to mandate universal implementation of available technologies, as well as support reimbursement policies to offset costs. The NEJM authors state “We believe the FDA should mandate a proactive approach, ensuring ongoing blood safety by requiring treatment of blood components by approved pathogen-reduction technologies.”
Read the full article (subscription required for full access)
Snyder, EL et al. N Engl J Med 2015; 372:1882-1885.
New 7-Year Haemovigilance Study Describes Routine Use of INTERCEPT Platelets
Results from an international, 21 center, 7-year haemovigilance study designed to further characterize the safety profile of INTERCEPT-treated platelet (PCT-PLT) components administered to a broad population were recently published in VoxSanuinis. Of the 4,067 patients who received 19,175 PCT-PLT, the incidence of acute transfusion reactions (ATR) were consistent with the lower range of per-patient reported ATRs for conventional PLTs. These data add to the growing evidence supporting the routine clinical use of PCT-PLTs.
Read the full article (open access, subscription not required)
Knutson, F et al. doi: 10.1111/vox.12287
Recent Article Explores the Financial Impact of Implementing Pathogen Reduction
A recent article  published in Transfusion examines the costs that could be eliminated with the adoption of pathogen reduction. The authors provide insight into cost implications with pathogen reduction as they relate to the replacement of specific tests, as well as  procedures and practices for the production of apheresis platelets in the US. Five institutions were surveyed to assess the potential replacement of current tests such as bacterial detection, potential future tests such as for dengue and Babesia, as well as the possible savings as a result of decreased platelet waste should 7-day storage licensing become available with pathogen reduction.
Read the full article here (open access, subscription not required)
McCullough, J et al. Transfusion. doi: 10.1111/trf.13149
WHAT WE'RE READING
Independent evaluation of tolerance of therapeutic plasma inactivated by amotosalen-HCI-UVA (INTERCEPT) over a 5-year period of extensive delivery
Bost, et al. Vox Sang. 2015 May 29. DOI: 10.1111/vox.12300
Read the abstract here (subscription required for full access)

Putting Chagas Disease on the US Radar Screen
Bridget, M et al. JAMA 2015;313(12):1195-1197. DOI: 10.1001/jama.2015.1867.
Read the abstract here (subscription required for full access)
 
Calendar of Events
ISBT 25th Regional Conference | June 27-July 1, 2015 | London, United Kingdom
AABB Annual Meeting | October 23-27, 2015 | Anaheim, CA
ISBT 26th Regional Conference | November 14-16, 2015 | Bali, Indonesia
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 platelet components intended for patients with a history of hypersensitivity reaction to amotosalen or other psoralens. Contraindicated for the preparation of platelets and plasma intended for neonatal patients treated with phototherapy devices that emit wavelengths less than 425 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.
MAN-EN-00165
Copyright © 2015 Cerus Corporation, All rights reserved.


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