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Vaccines, Blood & Biologics

Public Workshop: Application of Advances in Nucleic Acid and Protein Based Detection

Methods to Multiplex Detection of Transfusion-Transmissible Agents
and Blood Cell Antigens in Blood Donations

April 10, 2013
8:00 a.m. to 5:30 p.m.

April 11, 2013
8:00 a.m. to 5:00 p.m.

Workshop Goals and Objectives:
The Food and Drug Administration (FDA) is announcing a public workshop entitled: “Application of Advances in Nucleic Acid and Protein Based Detection Methods to Multiplex Detection of Transfusion-Transmissible Agents and Blood Cell Antigens in Blood Donations.”  The purpose of this public workshop is to discuss research and development of multiplex assays and the use of these tests in blood donor screening and blood cell antigen typing.

The objectives of the workshop are to review the status of multiplex platforms and the technological advances in gene based and protein based pathogen and blood cell antigen detection methods and to discuss the scientific pathways to support the development of multiplex assays to screen blood donors for blood-borne pathogens and blood cell antigen typing.  The first day of this workshop will include presentations and panel discussions on the following topics:  (1) blood safety and infectious agents; (2) advances in blood-borne pathogen detection; and (3) molecular DNA-based typing of blood cell antigens.  The second day of the workshop will include presentations and discussion on the following topics: (1) highly multiplexed technologies in blood donor screening; (2) bioinformatics, data analysis and data management issues and (3) perspectives in developing multiplex devices for donor screening; and (4) workshop summary and conclusions.

The workshop has been planned in partnership with the AABB, Advanced Medical Technology Association (AdvaMed), America’s Blood Centers, Department of Defense, Department of Health and Human Services Office of the Assistant Secretary for Health and the National Heart, Lung and Blood Institute, National Institutes of Health.  The workshop will include presentations and panel discussions by experts from academic institutions, blood establishments, industry, and government agencies.

Main Auditorium
Natcher Conference Center
Building 45
National Institutes of Health
Bethesda, MD 20892

There is no registration fee for the workshop.  Early registration is recommended before April 1, 2013, as seating is limited.  Registration on the day of the workshop will be provided on a space available basis beginning at 7:30 a.m. To register, complete the attached registration form in this announcement and mail, fax or e-mail it to Jennifer Scharpf, Food and Drug Administration, HFM-300, 1401 Rockville Pike, Rockville, MD 20852; Fax: 301-827-2843; E-mail:

Contact Person:
Jennifer Scharpf, MPH
Food and Drug Administration
Office of Blood Research & Review
Center for Biologics Evaluation and Research
1401 Rockville Pike, HFM-300
Rockville, MD 20852
Phone: 301-827-6128
Fax: 301-827-2843

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