2006D-0347:
Guidance for
Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic
Multivariate Index Assays
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| Document #
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| Received Date
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| Filed
Date
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| Submitter Code
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| Submitter
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| FR
Date
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| FR
Page
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| Comment Date
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| Files
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| Remarks
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| NAD1
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| 09/05/2006
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| FDA
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| FDA
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| 09/07/2006
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| 52800-52801
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| 12/06/2006
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| txt
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| Signature:
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| SHUREN, JEFFREY
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| GDL1
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| 09/05/2006
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| 09/05/2006
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| Federal Government
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| Guidance
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| pdf
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| EC1
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| 09/22/2006
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| 09/21/2006
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| Individual Consumer
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| self
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| htm
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| Signature:
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| Ferraro, Phil
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| EC2
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| 10/05/2006
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| 10/04/2006
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| Private Industry
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| NHIC - CA Medicare
Part B Contractor
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| htm
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| Signature:
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| Quinn, Bruce
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| EC3
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| 10/06/2006
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| 10/05/2006
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| Private Industry
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| InterGenetics Incorporated
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| htm
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| Signature:
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| Shimasaki, Craig
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| EC4
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| 10/10/2006
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| 10/06/2006
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| Association
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| Genetic Alliance
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| htm
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| Signature:
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| Malkoc, Orkideh
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| EC5
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| 10/18/2006
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| 10/13/2006
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| Device Industry
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| GHC Technologies,
Inc.
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| htm
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| Signature:
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| Stoughton, Roland
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| EC6
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| 10/25/2006
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| 10/20/2006
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| Health Professional
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| Dr. Jon Rosenblatt
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| htm
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| EC7
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| 11/03/2006
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| 11/02/2006
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| Academia
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| Genetics and Public
Policy Center
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| htm
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| Signature:
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| Hudson, Kathy
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| EC8
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| 11/14/2006
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| 11/13/2006
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| Device Industry
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| Prediction Sciences
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| htm
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| Signature:
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| Linke, Steven
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| EC9
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| 11/21/2006
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| 11/20/2006
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| Health Professional
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| Genomic Health, Inc.
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| htm
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| Signature:
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| Scott, Randy
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| EC10
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| 11/21/2006
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| 11/20/2006
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| International Organization
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| Public Health Genetics
Unit
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| htm
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| Signature:
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| Zimmern, Ronald
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| EXT1
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| 11/21/2006
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| 11/20/2006
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| Drug Industry
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| Aureon Laboratories,
Inc.
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| pdf
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| Signature:
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| Vijay Aggarwal, PhD
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| C1
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| 11/21/2006
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| 11/16/2006
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| Health Care Association
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| Mayo Clinical Trial
Services
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| pdf
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| Signature:
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| Lawrence K. Oliver, PhD
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| EC11
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| 11/27/2006
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| 11/26/2006
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| Health Professional
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| M. D. Anderson Cancer
Center
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| htm
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| Signature:
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| Grossman, H. Barton
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| NEC1
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| 11/27/2006
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| FDA
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| FDA
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| 11/28/2006
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| 68822-68823
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| 03/05/2007
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| txt
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| Signature:
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| SHUREN, JEFFREY
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| C2
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| 12/05/2006
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| 12/04/2006
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| Private Industry
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| Insilicos LLC
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| pdf
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| Signature:
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| Erik Nilsson
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| EC12
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| 12/07/2006
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| 12/06/2006
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| Drug Industry
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| Eli Lilly and Company
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| htm
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| Signature:
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| Allison, Christine
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| NM1
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| 01/08/2007
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| FDA
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| FDA
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| 01/09/2007
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| 967-968
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| 03/05/2007
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| txt
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| Signature:
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| Jeffrey Shuren
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| EC13
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| 01/19/2007
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| 01/18/2007
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| Consumer Group
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| Research Advocacy
Network
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| htm
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| Signature:
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| Railey, Elda
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| EC14
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| 01/31/2007
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| 01/30/2007
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| Health Professional
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| McDermott, Will
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| pdf
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| Signature:
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| Radensky, Paul
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| EC15
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| 02/12/2007
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| 02/01/2007
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| Device Industry
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| Exagen Diagnostics,
Inc.
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| pdf
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| Signature:
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| Popper, Caroline
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| EC16
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| 02/12/2007
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| 02/01/2007
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| Academia
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| Baylor College of
Medicine - Dept of Genetics
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| pdf
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| Signature:
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| Beaudet, Arthur
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| EC17
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| 02/12/2007
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| 02/01/2007
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| Association
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| Ovarian Cancer National
Alliance
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| pdf
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| Signature:
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| Salway-Black, Sherry
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| EC18
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| 02/12/2007
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| 02/01/2007
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| Health Care Association
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| association of american
physician and surgeons
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| pdf
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| Signature:
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| ostrolenk, michael
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| TS1
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| 02/02/2007
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| 02/02/2007
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| Academia
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| Baylor College of
Medicine
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| Letter,
Presentation (pdf) (ppt)
(htm)
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| Signature:
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| R Joel Slomoff, Dr Arthur Beaudet
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| TS2
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| 02/07/2007
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| 02/02/2007
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| Academia
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| Genetics and Public
Policy Center, Johns Hopkins University
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| pdf
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| Signature:
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| Gail Javitt JD MPH
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| C3
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| 02/13/2007
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| 02/08/2007
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| Association
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| BlueCross BlueShield
Association
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| pdf
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| Signature:
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| Allan M Korn MD FACP
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| EC19
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| 02/22/2007
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| 02/01/2007
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| Health Care Association
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| Association for Molecular
Pathology
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| htm
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| Signature:
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| Williams, Mary Steele
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| EC20
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| 02/22/2007
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| 02/01/2007
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| Health Care Association
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| American Clinical
Laboratory Association
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| pdf
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| Signature:
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| Mertz, Alan
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| EC21
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| 02/22/2007
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| 02/01/2007
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| Device Industry
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| Exagen Diagnostics,
Inc.
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| pdf
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| Signature:
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| Popper, Caroline
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| EC22
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| 02/22/2007
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| 02/01/2007
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| Drug Industry
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| Genzyme Genetics
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| pdf
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| Signature:
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| Aspinall, Mara
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| EC23
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| 02/22/2007
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| 02/01/2007
|
| Private Industry
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| Mr. David Levison
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| pdf
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| EC24
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| 02/22/2007
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| 02/01/2007
|
| Device Industry
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| Mr. Jonathan Cohen
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| htm
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| C4
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| 02/13/2007
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| 02/12/2007
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| Association
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| College of American
Pathologists
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| pdf
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| Signature:
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| Thomas Sodeman MD
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| C5
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| 02/16/2007
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| 02/13/2007
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| Association
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| American Association
for Clinical Chemistry (AACC)
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| pdf
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| Signature:
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| Larry Broussard PhD
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| C6
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| 03/01/2007
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| 02/28/2007
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| Association
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| American Clinical
Laboratory Association
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| pdf
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| Signature:
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| Alan Mertz
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| C7
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| 02/28/2007
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| 02/23/2007
|
| Individual Consumer
|
| H. Schiff
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Page last updated:
March 14, 2007
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