Assessing the clinical utility of genetic tests: implications for health technology assessment

Abstract

Already commonplace in many health systems, genetic tests will become more readily available in the future. Assessments of these new technologies must consider a number of unique factors regarding the types of health outcomes that might arise. This paper examines the issues relating to the assessment of the health and psychosocial outcomes of genetic tests. We argue that diagnostic genetic tests are similar to diagnostic non-genetic tests, in that their primary utility results from the effectiveness of subsequent treatments. Thus, these tests can be assessed using standard procedures for measuring changes in health outcomes. Predictive and pre-dispositional tests may also result in improved health outcomes, but achieving these benefits may require that individuals significantly alter their health behaviours. Assessments of these tests must consider the extent to which individuals will alter their health behaviours and life decisions.