edited by Jan T Jørgensen (CMC Contrast, Denmark) & Henrik Winther (Dako, Denmark)

This unique book provides a thorough overview of developing molecular cancer diagnostic assays, which are the prerequisites for optimal solutions within personalized cancer medicine. The book takes the reader through definitions of the pharmacodiagnostic concept, historical perspectives of the early steps into molecular cancer diagnostics linked to therapy, the basis of different diagnostic molecular techniques, ongoing research, drug-diagnostic co-development, assay validation, clinical trial methodology, regulatory issues around pharmacodiagnostics and future aspects within personalized cancer medicine.

The book is the first of its kind to cover relevant subjects around molecular cancer diagnostics when used as important drivers in personalized cancer medicine. The different chapters of the book are authored by key opinion leaders, each representing their specialized areas, which provide the reader with expertise knowledge in the field.

Molecular Diagnostics — The Key Driver in Personalized Cancer Medicine is an essential book that may be used as a source of reference by oncologists, physicians, pathologists and research scientists within molecular diagnostics. It is also a suitable read for graduate students.

• Introduction (H Winther & J T Jørgensen)
• Developing Molecular Diagnostics in Cancer (H Winther & J T Jørgensen)
• The Estrogen & Progesterone Receptors — Setting the Scene for Pharmacodiagnostics (K-L Cheung)
• The Development of the Herceptest™ — From Bench to Bedside (J T Jørgensen & H Winther)
• Predictive Biomarkers and Translational Cancer Medicine (A-S Schrohl et al)
• Pharmacodiagnostic Testing — Immunohistology (A S-Y Leong & T Y-M Leong)
• In Situ Hybridisation for Pharmacodiagnostic Testing (J M S Bartlett & F M Campbell)
• MammaPrint^® Translating Research into a Diagnostic Test (A M Glas et al.)
• DNA Biomarkers in the Diagnosis and Management of Cancer (R R Serizawa & P Guldberg)
• Validating the Analytical Power and Parameters of an Immunohistochemical Test (C Nielsen)
• Drug and Pharmacodiagnostic Co-Development Statistical Considerations (R Simon)
• Clinical Validation of Biomarkers in Cancer (S J Mandrekar & D J Sargent)
• Pharmacogenomic Markers for Cancer Therapy (S Marsh)
• Safety and Effective Biomarkers in Oncology — A Regulatory Drug and Device Perspective (A Rahman & F Kalush)
• Personalizing Treatment Selection for Breast Cancer (L Pusztai & C C Yeoh)
• Pharmacodiagnostics and Personalized Medicine in Cancer (J T Jørgensen)