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Table 1 Ethical issues associated with the use of companion diagnostics [46]

From: Personalized medicine in Europe: not yet personal enough?

Issue Concern
Informed consent • The process of getting consent from the patient for testing is both lengthy and complex
Data management • Testing generates data which should be identifiable and integrated into datasets of genomic and health information
• Interpreting test data requires skilled professionals who are able to interpret and translate the data to patients
Communication of results • Translating the results to patients is becoming increasingly difficult, as the number of biomarkers being tested by a single test is constantly increasing
• Testing can provide incidental findings and variants of unknown significance, knowledge of which can affect a patient’s well-being
• Patients have concerns about privacy and the possible disclosure of genetic information. They have concerns about who sees their results during the analysis process and a potential risk of discrimination if such information is known
Cost and equity issues • The costs for targeted therapies are usually high; drugs and accompanying tests might not always be covered by health insurance, which can limit patients’ access to treatment
• High costs increase the imbalance in access to new and better treatments as the identification of new biomarkers and treatments continues
Guidelines • There is a lack of guidelines regarding implementation of testing