A comprehensive overview of molecular diagnostics and their crucial role in advancing personalized cancer medicine. The texts primarily discuss the development and validation of various predictive and prognostic biomarkers, particularly focusing on immunohistochemistry (IHC) and in situ hybridization (ISH) techniques for detecting genetic alterations like HER2 overexpression and gene amplifications. Significant attention is given to the analytical and clinical validation processes required for these assays, including the challenges of assay standardization, pre-analytical variables like tissue fixation, and regulatory pathways for co-developing drugs and companion diagnostics (CDx), such as with the example of trastuzumab and HercepTest™. Finally, the sources explore clinical trial designs for evaluating CDx and the importance of pharmacogenomic markers for predicting drug efficacy and toxicity, particularly in endocrine therapies.
You can listen and download our episodes for free on more than 10 different platforms:
https://linktr.ee/medicine_made_simple
Produced by:
https://www.podcaistudio.com/