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Development of a Diagnostic Microarray for Lymphoma Diagnosis and Prognosis. Collaboration:. Lymphoma/Leukemia Molecular Profiling Project (LLMPP) and Roche Diagnostics. AmpliChip Lymphoma Global Biomarker Discovery & Feasibility Program. Lymphoma US: 3 centers, EU: 4 centers, Canada.
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Development of a Diagnostic Microarray for Lymphoma Diagnosis and Prognosis Collaboration: Lymphoma/Leukemia Molecular Profiling Project (LLMPP) and Roche Diagnostics
AmpliChip LymphomaGlobal Biomarker Discovery & Feasibility Program Lymphoma US: 3 centers, EU: 4 centers, Canada
AmpliChip LymphomaLLMPP-Roche Study program timeline June 2006 March 2007 Dec. 2007 Pre-Phase STAGE I STAGE II n = 20 tests/site HG-U133 Plus 2.0 AmpliChip Lymphoma Gold Standard tests Gold Standard tests n = 200 patients/site n = 200 patients/site June - October 2006: Standardization & Proficiency Test
# of Detected Genes CV (%) BRAIN UHR
AmpliChip Leukemia TestAnalysis of Second Round of Training/Proficiency MCF-7 MCF-7 BRAIN BRAIN UHR UHR HEPG2 HEPG2
Hierarchical Clustering (top 5,000 CV filtered probe sets)
AmpliChip Leukemia TestAnalysis of Second Round of Training/Proficiency MCF-7 Cell line Study Laboratory Stage Operator Input RNA
Clinical translation of gene expression profiling results – where do we go? • Formalin-fixed and paraffin embedded tissue (FFPE) • Immunohistochemistry • Quantitative molecular methods (qRT-PCR) that are applicable in FFPE tissue • Fresh frozen tissue • Development of a diagnostic microarray
Acknowledgements Lymphoma/Leukemia Molecular Profiling Project (LLMPP) (Louis M. Staudt, John Chan, Elias Campo, Randy Gascoyne, Andrew Lister, Erlend Smeland, Rich Fisher, George Wright, Andreas Rosenwald et al.) Lunenburg Lymphoma Biomarker Consortium (LLBC) (Daphne de Jong, Gilles Salles, Randy Gascoyne, Edie Weller, A. Hagenbeek, Sandra Horning, Andrew Lister, Andreas Rosenwald et al.) Rosenwald / Campo Laboratories ( Elena Hartmann, Nica Fernandez, Victor Moreno et al.)