ABSTRACT

Biomarkers in personalized medicine have to reflect features of individual diseases in various biological matrices by employing a huge variety of different analytical methods. In order to allow identification of the molecular features of individual diseases and to enable an integrated data analysis of samples from different sources, the quality of biosamples is now very important. There are several international standards, such as CEN Technical Specifications and ISO standards, which define quality requirements for biosamples for diagnostic test manufacturers and diagnostic laboratories, and which are also relevant for regulators, researchers and biobanks. Furthermore, biosamples have to be associated with detailed information on the patient and disease, including imaging data, making data management (and privacy protection) increasingly important. These requirements led to the establishment of dedicated biobanks that collect, process, store and provide access to biosamples and associated medical data in a quality-controlled and ethically and legally compliant manner. Biobanks are established under professional governance and cover a broad spectrum of different biosamples ranging from tissues to essentially all types of body fluids containing analytes such as nucleic acids (including free circulating nucleic acids), proteins and metabolites as well as various isolated cell types and their derivatives, such as induced pluripotent stem cells. In this section, we outline features of biobanking that are crucial for high-quality research into biomarkers for precision medicine.