The Key Driver in Personalized Cancer Medicine
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 are authored by key opinion leaders, each representing their specialized areas, so that the reader can gain expertise 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.
* Developing Molecular Diagnostics for Cancer (H Winther & J T Jørgensen)
* The Estrogen & Progesterone Receptor — Setting the Scene for Pharmacodiagnostics (K L Cheung)
* The HercepTest® — From Bench to Bedside (J T Jørgensen & H Winther)
* Pharmacodiagnostics and Translational Cancer Medicine (F G Rojo Todo)
* Pharmacodiagnostic Testing — Immunohistology (A S-Y Leong & T Y-M Leong)
* In Situ Hybridisation for Pharmacodiagnostic Testing (J Bartlett & F M Campbell)
* Pharmacodiagnostics Test — Microarray (A Glas)
* DNA Biomarkers in the Diagnosis and Management of Cancer (R R Serizawa & P Guldberg)
* Validating the Analytical Power of a Pharmacodiagnostic Test (C Taylor)
* 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 Efficacy Biomarkers in Oncology Drug Label and Clinical Usage: A Regulatory Perspective (A Rahman & F Kalush)
* Image Analysis Systems for Cancer Diagnostics (K Bloom)
* Personalizing Treatment Selection for Breast Cancer (L Pusztai)
* Pharmacodiagnostics and Personalized Medicine in Cancer (J T Jørgensen)
The editors have recruited a highly experienced group of both academic medical center and industry-based international authors and produced a concise yet thorough overview of the emerging field of integrated diagnostics and personalized medicine. This book emphasizes slide-based companion pharmacodiagnostics, but also covers in depth post-extraction DNA sequence-based and mRNA profiling-based prognostic and predictive tests for both solid tumors and hematologic malignancies. Chapters on test development, regulatory approval and important consideration of test validation and clinical utility round out this impressive work. Not only will academic departments and cancer centers find this book to be an authoritative reference volume, but also 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.~Prof. Jeffrey S. Ross, Albany Medical College, USA
The topics and information covered in the book are the ones highly demanded in the current clinical biomarker sciences. This volume has successfully made a comprehensive coverage from all the experts in biomarker discovery, development, clinical trial and statistical validation, and practical use. This is definitely one of the references that everyone in this area should have.~Prof. Jae K. Lee, University of Virginia, USA