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In this Issue
SunCoast Blood Bank First in US to Provide Pathogen Reduced Platelets | Bonfils Blood Center and UNYTS Adopt the INTERCEPT Blood System
 | Potential for Nationwide Babesia Testing Raises Industry Concerns  | Cerus Appoints New Chief Medical Officer | Largest, systematic review of TA-GVHD Cases Published in Blood  What We're Reading | Calendar of Events
SunCoast Blood Bank First in US to Provide Pathogen Reduced Platelets
The first pathogen-reduced platelet units have been produced in the continental US by SunCoast Blood Bank (SCBB) and, in a region where emerging pathogens such as chikungunya and dengue present new threats to the safety of our blood supply, this represents an important step toward making blood platelet transfusions safer for patients in Southwest Florida. 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 and healthcare providers.
Read the full press release here.

 
Bonfils Blood Center Adopts the INTERCEPT Blood System
Bonfils Blood Center, an affiliate of Blood Systems Inc., has signed a purchase agreement with Cerus for the INTERCEPT Blood System for platelets and plasma. Bonfils has been providing blood and blood products to more than 100 hospitals and healthcare facilities in Colorado and beyond for more than 70 years. Dr Tuan Le, medical director and vice president of medical affairs for Bonfils said “We are pleased to offer the use of INTERCEPT pathogen reduction to enhance the quality of care provided at the hospitals we serve and for the patients for which they provide treatment”.
Read the full press release here.
Learn more about Bonfils Blood Center here.

 
UNYTS and Cerus Enter into Agreement for the INTERCEPT Blood System
UNYTS is the latest blood center to adopt the INTERCEPT Blood System for platelets and plasma pathogen reduction system. "Since adding community blood banking services in 2007, UNYTS has continuously strived to find ways to utilize the latest innovative technologies to improve safety and availability," said Mark Simon, UNYTS' President and CEO. "The INTERCEPT Blood System will provide a proactive approach to addressing the safety of our platelet and plasma recipients by protecting these patients from transfusion transmitted bacteria and emerging pathogens." UNYTS Provides blood components to eight counties in Western New York, supplying approximately 5,000 platelet and 11,000 plasma units per year.
Read the full press release here.
Learn more about UNYTS here.

 
Potential for Nationwide Babesia Testing Raises Industry Concerns
Despite recommendations from the US blood community, the FDA’s BPAC committee has recently endorsed nationwide serological testing for Babesia microti, in addition to NAT for donations collected in the nine earstern US states  that account for 98.5% of the babesiosis cases reported to the CDC. While mitigating the risk of Babesia transfusion-transmitted infection (TTI), the highest-ranking TTI pathogen in the US for which no screening is available, is a safety concern for centers in endemic areas, the financial repercussions are already being felt. Additional testing will result in upcharges for Babesia negative components from blood centers to hospitals which could result in hospitals seeking blood supplies from outside of the endemic areas.

There is no commercially available assay suitable for Babesia blood screening however, the FDA approved INTERCEPT Blood System for Platelets and Plasma pathogen reduction system has demonstrated high inactivation of Babesia microti ≥4.9 logs in both platelets1 and plasma2.

1INTERCEPT Blood System for Platelets [Package Insert]. Concord, CA: Cerus Corporation; 2014. 
2INTERCEPT Blood System for Plasma [Package Insert]. Concord, CA: Cerus Corporation; 2014.

 
Dr. Richard J. Benjamin Appointed as Cerus Corporation’s New CMO
Cerus Corporation has recently appointed Richard J. Benjamin, MD, PhD, FRCPath as chief medical officer (CMO) to lead the company’s clinical research and medical affairs efforts as the company pursues commercialization of the INTERCEPT Blood System in the US and advances the INTERCEPT red blood cell system beyond clinical development. Dr Benjamin joins Cerus from the American Red Cross where, in his role as CMO, he oversaw the organizations donor and patient safety issues related to blood collection and transfusion.

"The focus of my career has been to ensure the safety of both blood donors and patients who require blood transfusions. As we look to the future of blood safety and the news of patients worldwide, it is imperative that we take the most innovative path toward securing the US blood supply against new pathogens," Benjamin said. "I believe pathogen reduction is critical in this new era and in my new position, I look forward to assisting hospitals and blood banks in taking a proactive approach to reducing the risk of transfusion transmitted infections through adoption of the world's leading pathogen reduction system."
Read the full press release here.

 
A systematic review of transfusion-associated graft versus host disease (TA-GVHD)
A recent review in the journal Blood reports findings of the first, systematic review of all TA-GVHD cases reported in medical literature spanning 5 decades and 26 countries. Upon analysis of the 348 unique cases identified, the authors provide new insights into the mechanism of TA-GVHD and suggest a re-evaluation of necessity for irradiated blood components.
Kopolovic, I et al. Blood. 2015 Jul 16;126(3):406-14. doi: 10.1182.
Read the abstract here (subscription required for full access).
WHAT WE'RE READING
Cost-effectiveness of Babesia microti antibody and nucleic acid blood donation screening using results from prospective investigational studies
Bish, EK et al. Transfusion. 2015 May 21. doi: 10.1111/trf.13136.
Read the full abstract here.


Borrelia miyamotoi: The Newest Infection Brought to Us by Deer Ticks
Krause, PJ, Barbour, AG. 2015 Jun 9. doi: 10.7326/M15-1219. [Epub ahead of print]
Read the article here (subscription required for full access).

Independent evaluation of tolerance of therapeutic plasma inactivated by amotosalen-HCI-UVA (INTERCEPT™) over a 5-year period of extensive delivery
Bost, V et al. Vox Sang 2015 May 29. doi: 10.1111/vox.12300
Read the full abstract here.

 
CALENDAR OF EVENTS
America's Blood Centers Summer Meeting | August 4-6, 2015 | Philadelphia, PA
NIH Annual Immunohematology & Blood Transfusion Symposium | September 9, 2015 | Bethesda, MD
AABB Annual Meeting | October 23-27, 2015 | Anaheim, CA
ISBT 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  and plasma 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-00165-02
Copyright © 2015 Cerus Corporation, All rights reserved.


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