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FDA Issues Advisory to Blood Centers Amidst Local Zika Infections in Florida CMS Issues Proposed 2017 Payment Rates for Hospital Outpatient Billing of PR Platelets and Plasma | Blood Centers of America Members Continue the Move to Pathogen Reduction Technology | The Swiss Red Cross Humanitarian Foundation Awards Grant of 2 Million Swiss Francs for Whole Blood Pathogen Reduction for Africa | Science Section: What We're Reading | Calendar of Events
FDA Issues Advisory to Blood Centers Amidst Local Zika Infections in Florida
Several cases of locally acquired Zika infection in Florida prompted the FDA to take the precaution of requesting that all blood establishments in Miami-Dade County cease collecting blood immediately until such time as they can implement the use of an approved or investigational pathogen reduction technology or implement testing of each individual unit of blood with an available investigational donor screening test. FDA also recommends that adjacent and nearby counties implement these same precautions to help maintain the safety of the blood supply. Individuals who may have traveled to Miami-Dade are also deferred from donating for four weeks.
CMS Issues Proposed 2017 Payment Rates for Hospital Outpatient Billing of PR Platelets and Plasma
The Centers for Medicare & Medicaid Services (CMS) recently released proposed 2017 payment rates paid under the outpatient prospective payment system (OPPS). The proposed rate for a pathogen-reduced platelet unit continues to include a premium over the rate for a unit of conventional apheresis platelets.

The INTERCEPT Blood System is currently the only FDA-approved system for pathogen reduction of platelet and plasma components, designed to reduce the risk of transfusion-transmitted infections.

View the report
Blood Centers of America Members Continue the Move to Pathogen Reduction Technology
Blood Centers of America (BCA) members representing 54% of the aggregate volume of platelets produced by the whole BCA membership have executed participation agreements for adoption of the INTERCEPT Blood System under a master framework agreement. In March 2016, Cerus and BCA announced a 5-year agreement that called for BCA to actively promote the INTERCEPT Blood System for platelets and plasma to over 50 member blood centers, with a commitment to secure adoption from member centers representing a minimum of 50% of BCA’s aggregate volume.

Please view the press release for a list of BCA members now under contract for INTERCEPT
The Swiss Red Cross Humanitarian Foundation Awards Grant of 2 Million Swiss Francs for Whole Blood Pathogen Reduction for Africa
The Swiss Red Cross Humanitarian Foundation has awarded a grant of 2 million Swiss Francs to Cerus, the University Hospital of Basel, and the Swiss Transfusion SRC to complete the necessary clinical studies to develop a whole blood pathogen reduction system for use in Africa. While patients in developed countries receive platelet, plasma, or red cell transfusions, in many African countries, whole blood transfusions remain common, requiring the development of a robust whole blood pathogen reduction system optimized for use within the limited infrastructure of local blood banks and hospitals.

View the press release
Science Section: What We’re Reading

Suspected Female-to-Male Sexual Transmission of Zika Virus — New York City, 2016
Davidson A, Slavinski S, et al. Morb Mortal Wkly Rep 2016;65:716–717.
Read the report
Longitudinal follow-up of Zika virus RNA in semen of a traveller returning from Barbados to the Netherlands with Zika virus disease, March 2016.
Mögling R, van Kampen J, et al. Euro Surveill. 2016;21(23):pii=30251.
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Detection of Zika virus RNA in whole blood of imported Zika virus disease cases up to 2 months after symptom onset, Israel, December 2015 to April 2016
Paran N, Melamed S, Schwartz E. Euro Surveill. 2016;21(26):pii=30269.
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First report of the isolation of Lactococcus garvieae from a platelet concentrate in Japan
Kozakai M, Matsumoto M, et al. Transfusion 2016DOI:10.1111/trf.13752 (e-pub ahead of print)
Read the abstract
Calendar of Events

SABM Annual Meeting (Society for the Advancement of Blood Management)
September 29 - October 1, 2016 | Grand Rapids, Michigan
Additional Information

AABB (American Association of Blood Banks) Annual Meeting
October 22-25, 2016 | Orlando, FL
Additional Information

ASA Annual Meeting (American Society of Anesthesiologists)
October 22-25, 2016 | Chicago, IL

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 00165-14
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Cerus, INTERCEPT Blood System and INTERCEPT are registered trademarks of Cerus Corporation.

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