Recent developments in genomics have resulted in the increased availability of gene profiles for early diagnosis and prognosis in breast cancer. A request from a Dutch woman to have her tumour tissue tested years after treatment confronted the Netherlands Cancer Institute (NKI) and its staff with legal, ethical, and practical questions regarding patients' rights in relation to residual tissue storage and its use for clinical purposes. Was her tissue still available? If so, could she demand that the test be carried out or her tissue be transferred to another hospital? As it became apparent that appropriate guidance was lacking in this area, we developed guidelines on the issue, with the involvement of relevant professionals and patient representatives within the framework of a Technology Assessment project.1
Gene-expression profiling is an important development that is likely to predict the diagnosis and prognosis of malignant disease more accurately than existing clinicopathological parameters.2 Although gene-expression profiling is not yet routine, several tests are already applied in clinical practice. Additionally, the 70-gene signature (MammaPrint), which uses microarrays on fresh frozen tumour tissue, is being tested in a multicentre randomised trial (MINDACT).3 However, for such tests to be successful it is essential that sufficient tumour tissue is available.