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First U.S. Blood Center Submits Biologics License Application To The FDA to Allow For Interstate Export of INTERCEPT Platelet Components
The Community Blood Center (CBC) of Appleton, Wisconsin has submitted the first Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) requesting allowance for interstate distribution of platelets that have been pathogen-reduced via the INTERCEPT Blood System. “This first BLA submission is an important milestone for Cerus and for CBC as it improves patient access to INTERCEPT components,” said William “Obi” Greenman, Cerus’ president and chief executive officer. “A number of our other customers are also nearing their BLA submissions, moving us one step closer to supplying pathogen-reduced platelets to hospitals in any state in the U.S.” The Biologics License Application is a common procedure for blood centers to request permission by FDA to introduce a biologic product into interstate commerce (21 CFR 601.2). The FDA has up to 12 months to review each BLA submission. Until a blood center obtains a BLA, they are restricted to distributing INTERCEPT-treated products to hospitals within the state in which they are produced. While some blood centers may distribute primarily in state, many U.S. blood centers have extensive interstate distribution.
Read the Press Release
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CDC Identifies New Emerging Pathogen in the Carribean: Mayaro Virus
CDC recently reported on the diagonosis of a newly emerging arbovirus, the Mayaro virus, in Haiti.1
An 8-year-old child was confirmed positive for the virus after having complained about symptoms similar to chikungunya and dengue viruses. The Mayaro virus is an alphavirus thought to be transmitted by the Haemagogus mosquito; CDC believes the Aedes aegypti mosquito could be a vector as well. Originally isolated in Trinidad in 1954, the Mayaro virus was initially found in the Amazon forest; CDC’s recent findings suggest that the Mayaro virus is actively circulating in the Caribbean region. With the Zika virus still making headlines, the emergence of yet another infectious agent has caused some concern in the transfusion industry. Proactive measures such as pathogen reduction have been discussed as a possible method in which to mitigate such risks.2
The INTERCEPT Blood System for platelets and plasma target and crosslink DNA and RNA to prevent the replication of bacteria, parasites and viruses, including arboviruses such as dengue and chikungunya.
Read the CDC Article1
Read the ABC Newsletter2 (Subscription Required)
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AABB 2016 Abstracts Published in Transfusion
Abstracts from the AABB Annual Meeting taking place in Orlando, FL October 22-25, 2016 have been published in a special issue supplement of Transfusion. A number of pathogen reduction focused abstracts have been accepted for oral and poster presentations including:
Oral Presentation S43-030C | Monday, October 24th, 2016 | 2:00 pm - 2:15 pm | Room W224 C/D
Evaluation of Platelets in 100% Plasma Treated with Amotosalen-UVA (B Donnelly, et al.)
Oral Presentation S49-030D | Monday, October 24th, 2016 | 2:00 pm - 2:15 pm | Room W224 E/F
Amotosalen and UVA is More Effective In The Inactivation of T-Cells Than Gamma Irradiation When Assessed By a Limiting Dilution Assay (LDA) (PA Merke et al.)
Poster Presentation | October 22, 2016 | 12:00 pm-2:15 pm | Poster Hall
AP61 Implementation Of Psoralen-Treated Pathogen-Treated Pathogen-Reduced Platelets: A US Transfusion Service Perspective (M J Healy et al.)
SP439 Inactivation of Babesia Microti with Amotosalen/UVA in Platelets Concentrates Manufactured In 100% Plasma (L Tonnetti et al.)
SP441 Inactivation of Chikungunya Virus With Amotosalen/UVA In Platelets Concentrates Suspended In 100% Plasma (A Laughhun et al.)
SP454 Implementation of the INTERCEPT Blood System for Platelets In Puerto Rico to Help Safeguard Against Zika (E Weiner et al.)
Read the Abstracts here (subscription required for full access)
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Cerus Workshop at AABB Annual Meeting October 25, 2016: Pathogen Reduction: What’s Next? October 25, 2016, 7:00 am-8:15 am
Cerus AABB Workshop, Additional Details
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Science Section: What We’re Reading
Florida Health Officials Report Dengue Case
Florida Health Department, Florida Arbovirus Surveillance
Read the Report
Fatal Zika Virus Infection with Secondary Nonsexual Transmission
Swaminathan et al., N Engl J Med, 28 September 2016
Read the Correspondance
Varying Estimates of Sepsis Mortality Using Death Certificates and Administrative Codes
L Epstein et al, MMWR, 8 April 2016, 65(13):342-345
Read the Article
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Calendar of Events
AABB (American Association of Blood Banks) Annual Meeting
October 22-25, 2016 | Orlando, FL
Additional Information
ASA (American Society of Anesthesiologists) Annual Meeting
October 22-26, 2016 | Chicago, IL
Additional Information
ASH (American Society of Hematology)
December 3-6, 2016 | San Diego, CA
Additional Information
SCCM (Society of Critical Care Medicine)
January 21-25, 2017 | Honolulu, HI
Additional Information
BMT Tandem Meetings (Center for International Blood & Marrow Transplant Research & American Society for Blood and Marrow Transplantation)
February 22-27, 2017 | Orlando, FL
Additional Information
ABC (America's Blood Centers) Spring Meeting
March 24-29, 2017 | Washington DC
Additional Information
CSTM (Canadian Society for Transfusion Medicine)
April 20-23, 2017 | Ottowa, Canada
Additional Information
SCA (Society of Cardiovascular Anesthesiologists)
April 22-26, 2017 | Orlando, FL
Additional Information
ASPHO (The American Society of Pediatric Hematology/Oncology)
April 26-29, 2017 | Montreal, Canada
Additional Information
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Data for pathogen reduction of the ZIKA and Mayaro virus by the INTERCEPT Blood System, pathogen reduction system, have 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.
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 00165-16
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