MOLECULAR DIAGNOSTICS
The Key Driver in Personalized Cancer Medicine

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.

Contents:

• 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^TM — 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)

Readership: Oncologists, pathologists, academic cancer researchers and scientists and others working in the drug and diagnostic industries.

"The Editors have recruited a highly experienced group of both academic- and industry-based international authors and produced a concise yet thorough overview of the emerging field of integrated diagnostics and personalized medicine. Not only will academic departments and cancer centers find this book to be an authoritative reference volume, the pharmaceutical and biotechnology industries will be able to gain considerable insight that could play a major role in the shaping of their current and future products."

Jeffrey S Ross Albany Medical College, USA

"The topics and information covered in the book are highly in demand in the current clinical biomarker sciences. This volume successfully made a comprehensive coverage from all the experts in biomarker discovery, development, clinical trial & statistical validation, and practical use. This is definitely one of the references that everyone in this area should have."

Jae K Lee University of Virginia, USA

Key Features:

• First book of its kind
• An extensive coverage on the development of molecular cancer diagnostic assays by prominent researchers in the field
• Wide range of chapters with historical perspectives, fundamentals, advanced topics and future perspectives on personalized cancer medicine

364pp		Mar 2010
978-981-4241-44-1		US$159