Molecular Diagnostics

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.

Dr Jan Trøst Jørgensen holds an MSc degree in pharmacy and a PhD in clinical pharmacy from the Faculty of Pharmaceutical Sciences, University of Copenhagen. He has worked with drug development in biotech and pharmaceutical companies for more than 25 years, and within the last 10 years his focus has been on drug-diagnostic co-development projects within cancer. Dr Jørgensen is a strong supporter of more individualized pharmacotherapy and has published a number of scientific papers on oncology as well as on stratified and personalized medicine.

Developing Molecular Diagnostics for Cancer, H Winther & J T JørgensenThe Estrogen & Progesterone Receptor — Setting the Scene for Pharmacodiagnostics, K L CheungThe HercepTest® — From Bench to Bedside, J T Jørgensen & H WintherPharmacodiagnostics and Translational Cancer Medicine, F G Rojo TodoPharmacodiagnostic Testing — Immunohistology, A S-Y Leong & T Y-M LeongIn Situ Hybridisation for Pharmacodiagnostic Testing, J Bartlett & F M CampbellPharmacodiagnostics Test — Microarray, A GlasDNA Biomarkers in the Diagnosis and Management of Cancer, R R Serizawa & P GuldbergValidating the Analytical Power of a Pharmacodiagnostic Test, C TaylorDrug and Pharmacodiagnostic Co-Development Statistical Considerations, R SimonClinical Validation of Biomarkers in Cancer, S J Mandrekar & D J SargentPharmacogenomic Markers for Cancer Therapy, S MarshSafety and Efficacy Biomarkers in Oncology Drug Label and Clinical Usage: A Regulatory Perspective, A Rahman & F KalushImage Analysis Systems for Cancer Diagnostics, K BloomPersonalizing Treatment Selection for Breast Cancer, L PusztaiPharmacodiagnostics and Personalized Medicine in Cancer, J T Jørgensen