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Built on a decade of experience with novel molecular diagnostics, this practice-oriented guide shows how to cope with validation issues during all stages of biomarker development, from the first clinical studies to the eventual commercialization of a new diagnostic test.
List of contents
History of BiomarkersBiomarkers from the Discovery Phase to the Final AssaySample TypesBiomarkers - Past and FutureQuantitative Proteomics Techniques in Biomarker DiscoveryBiomarker qualification: a company point of viewBiomarker discovery and medical diagnostic imagingBreath: an often overlooked medium in biomarker discoveryHTA in personalized medicine technologiesBone Remodeling Biomarkers: New Actors on the Old Cardiovascular StageIdentification and Validation of Breast Cancer BiomarkersEvaluation of proteomic data: from profiling to network analysis by way of biomarker discoveryBiomarkers: From discovery to commercializationClinical validation chapter for biomarker validation bookGenomics and Proteomics for Biomarker Validation
About the author
Harald Seitz studied Biochemistry at the Free University of Berlin, accomplished his PhD working at the MPI for Molecular Genetics in 2000 and finished his habilitation at the University of Kassel in 2012. After working for nearly 10 years at the MPI for Molecular Genetics he moved to the Fraunhofer Institute for Biomedical Engineering in 2011. The focus of his work is on high throughput techniques especially all kinds of protein and peptide microarrays and in vitro diagnostics.
Sarah Schumacher studied Biology at the Free University of Berlin and completed her M.Sc. at the Humboldt University of Berlin. Before she started her PhD in 2013, she worked at the MPI for Molecular Genetics in Berlin and moved to the Fraunhofer IBMT in Potsdam-Golm in 2011. Her research interest is on biomarker and antibody validation.
Summary
Built on a decade of experience with novel molecular diagnostics, this practice-oriented guide shows how to cope with validation issues during all stages of biomarker development, from the first clinical studies to the eventual commercialization of a new diagnostic test.
