Molecular biomarker tests contribute to early diagnostics and personalized medicine. However, little is known about how these tests are used by healthcare professionals and patients and the ethical and legal dilemmas they experience. This project explores several pilot studies in the fields of oncology and psychiatry with the aim to provide advice on how the technology of biomarker tests can be responsibly embedded in healthcare.

The development of biomarker tests enables patient stratification and personalized therapies. These tests are promised to support early diagnostics of diseases and provide better insight into which treatments are suitable for a specific patient. While biomarker tests look very promising, they are not used at a large scale in medical clinics yet. This project aims to uncover barriers, opportunities and dilemmas for using biomarker tests in healthcare and to develop, together with different stakeholders, criteria for a responsible usage of biomarker tests.

To actually realize healthcare innovation it is not sufficient to pay attention to the optimalization of the new technology alone. At the same time, it is also necessary to think about the ‘social innovation’ that is needed to get doctors to actually use the technology and for patients and patient organisations to be pleased with the provided care. Which possible new roles, responsibilities, values, norms, and collaborations are required to make optimal use of these new technological developments? Little is known about how doctors and patients use biomarker tests, and about their experiences with these tests.

This project therefore aims to answer the following questions: Under which ethical, legal and societal conditions can biomarker tests be embedded in oncological and psychiatric healthcare? How can these conditions be taken on board in the further development of biomarker tests?

More specifically, the project targets the following four aspects:

• Identify discrepancies between perspectives and values of stakeholders regarding the transition towards personalized medicine in oncology and psychiatry;
• Analyse which and how values are inscribed into existing biomarker pilot studies in oncology and psychiatry;
• Explore how healthcare professionals and patients experience biomarker tests in their daily and professional practices, including the ethical and juridical dilemmas they experience;
• Co-creation of responsible design principles together with, for example, health professionals, companies, patients and insurance companies for the further development and embedding of biomarker tests in oncology and psychiatry.

By building upon several case studies in the fields of oncology and psychiatry, the goal is to reveal the differences and bottlenecks between scientific and technological promises on the one hand, and the needs, worries, and wishes of users (doctors and patients) on the other hand. This should lead to advices on how the technology of biomarker tests can be embedded in a responsible way and to criteria to better align the promises and the needs around biomarker tests in the design of these tests. How can issues such as privacy of medical data, changing medical practices, and responsibility of various stakeholders be taken into account in the design of biomarker tests?

This NWO-MVI research project is inked to the ‘Building Blocks of Life’ project ‘Dissecting the DNA damage response in three dimensional tumor tissue slice cultures’ that stands under supervision of prof. dr. Roland Kannaar, Erasmus MC.