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First Biologics License Application FDA Approved, Enabling Interstate Distribution of INTERCEPT Platelets |  AABB Posters Focus on INTERCEPT Platelet Hospital Implementation  |  Report Assesses Residual Risk of Sepsis with Pathogen Reduction or Delayed Large Volume Culture |  Science Section: What We're Reading  |  Calendar of Events
First Biologics License Application FDA Approved, Enabling Interstate Distribution of INTERCEPT Platelets
Rhode Island Blood Center received approval by the U.S. Food and Drug Administration (FDA) on its Biologics License Application (BLA) requesting allowance for interstate distribution of platelets that have been pathogen-reduced with the INTERCEPT Blood System. Seven additional blood centers have submitted BLAs.

“Rhode Island Blood Center now has the ability to ship INTERCEPT treated blood components across state lines to hospitals in regions where demand has exceeded supply due to various factors,” said William “Obi” Greenman, Cerus’ president and chief executive officer.

“We can now offer INTERCEPT treated blood components not just in Rhode Island but throughout Southern New England and with our New York Blood Center network of affiliated blood centers,” said Lawrence Smith, chief executive officer of the Rhode Island Blood Center.

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AABB Posters Focus on INTERCEPT Platelet Hospital Implementation
Several posters that describe experiences in US hospitals, including UCSD and Yale-New Haven Hospital, on the implementation of pathogen reduced platelets were presented at the annual AABB congress earlier this month. Posters included:
  • Roswell Park Cancer Institute – “The Effects of PAS and PR on Platelet Use” evaluates the utilization of platelet and red blood cell components before and after implementation of and transfusion of pathogen reduced platelet components.
  • University of California, San Diego (UCSD) - “Phased Implementation of Pathogen-Reduced Platelets in a Health System” describes an implementation strategy in which pathogen reduced platelets are distributed initially to specific patient groups, thus allowing time for the blood center to scale up manufacturing.
  • Yale-New Haven Hospital – “Logistical Management of the Incorporation of Pathogen Reduced Single Donor Platelets into Inventory at a U.S. Tertiary Care Medical Center” presents Yale’s roll-out of pathogen reduced platelet components, including the strategy with regard to supporting a dual inventory, and approach to training of personnel and key committees.
View the Posters
Report Assesses Residual Risk of Sepsis with Pathogen Reduction or Delayed Large Volume Culture
A recent report evaluated national hemovigilance (HV) data from the United Kingdom (UK), France, Switzerland, and Belgium to determine the efficacy of delayed large volume culture (DLVC) and pathogen reduction (PR). In the UK, from 2011 to 2016, approximately 1.65 million DLVC screened platelet components were issued with one septic reaction and 8 near miss contaminated units intercepted before transfusion. An overall contamination rate of 5.4 per million issued components was reported for this time period, a rate 66% lower than that reported in the prior 5 years without DLVC (16.3 per million). In aggregate, Belgian, Swiss and French hemovigilance programs monitored 609,290 pathogen reduced platelet components, with zero reported septic reactions or fatalities, or a rate of <1.6 per million. This was significantly less that that reported for non-PR units in which there were 71 septic reactions and 12 fatalities out of 2.98 million non-PR platelet components screened (23.8 and 4.0 per million, respectively).

Benjamin RJ et al. Hemovigilance monitoring of platelet septic reactions with effective bacterial protection systems. Transfusion. 2017 Aug; Epub ahead of print.

View the Abstract
Science Section: What We’re Reading

St. Louis encephalitis virus possibly transmitted through blood transfusion—Arizona, 2015.
Venkat H et al. Transfusion. 2017 Sep; Epub ahead of print.
Read the Abstract

Inactivation of Babesia microti in red blood cells and platelet concentrates.
Tonnetti L et al. Transfusion. 2017 Oct;57(10):2404-2412.
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Delayed presentation of a septic transfusion reaction.
Nelson RC et al. Transfusion. 2017. Oct;57(10):2309-2310.
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Apheresis technology correlates with bacterial contamination of platelets and reported septic transfusion reactions.
Eder AF et al. Transfusion. 2017 Sep; Epub ahead of print.
Read the Abstract

Crisis in the Sustainability of the U.S. Blood System.
Klein HG et al. NEJM. 2017 Oct 12;377(15):1485-1488.
Read the Abstract
Calendar of Events

BMT/ASBMT Tandem Meeting
Feb 21-28, 2018
San Francisco, CA

Society of Critical Care Medicine (SCCM) Annual Meeting
Feb 24-28, 2018
San Antonio, TX

America’s Blood Centers Annual Meeting
March 17-19, 2018
Scottsdale, AZ

April 24-28, 2018
Glendale, AZ

Society of Cardiovascular Anesthesiologists (SCA) Annual Meeting
April 28-May 2, 2018
Phoenix, AZ

American Society of Pediatric Hematology/ Oncology (ASPHO) Annual Meeting
May 2-5, 2018
Pittsburgh, PA

35th International Congress of the ISBT
June 2-6, 2018
Toronto, Canada

American Society of Anesthesiologists Annual Meeting (ASA)
Oct 13-17, 2018
San Francisco, CA

AABB Annual Meeting
Oct 13-16, 2018
Boston, MA

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.

INTERCEPT Blood System for Red Blood Cells is in development and not available for sale.

Rx only. For full prescribing information, please see package insert.
MKT-EN 00165-27
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Cerus, INTERCEPT Blood System and INTERCEPT are registered trademarks of Cerus Corporation.

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