Introduction / Jan Trs?t Jr?gensen and Henrik Winther -- Developing molecular diagnostics in cancer / Henrik Winther and Jan Trs?t Jr?gensen -- The estrogen and progesterone receptors : setting the scene for pharmacodiagnostics / Kwok-Leung Cheung -- The development of the HercepTest : from bench to bedside / Jan Trs?t Jr?gensen and Henrik Winther -- Predictive biomarkers and translational cancer medicine / Anne-Sofie Schrohl [and others] -- Pharmacodiagnostic testing : immunohistology / Anthony S.-Y. Leong and Trishe Y.-M. Leong -- In situ hybridisation for pharmacodiagnostic testing / John M.S. Bartlett and Fiona M. Campbell -- MammaPrint translating research into a diagnostic test / Annuska M. Glas, Leonie Delahaye and Oscar Krijgsman -- DNA biomarkers in the diagnosis and management of cancer / Reza Rafiolsadat Serizawa and Per Guldberg -- Validating the analytical power and parameters of an immunohistochemical test / Sr?en Nielsen -- Drug and pharmacodiagnostic co-development : statistical considerations / Richard Simon -- Clinical validation of biomarkers in cancer / Sumithra J. Mandrekar and Daniel J. Sargent -- Pharmacogenomic markers for cancer therapy / Sharon Marsh -- Safety and effective biomakers in oncology : a regulatory drug and device perspective / Atiqur Rahman and Francis Kalush -- Personalizing treatment selection for breast cancer / Lajos Pusztai and Chit Cheng Yeoh -- Pharmacodiagnostics and personalized medicine in cancer / Jan Trs?t Jr?gensen.