Grant: Project Grant

How do new diagnostic tests find their way into practice? What are the relative roles of industry and the public sector in the discovery, development and adoption of new biological markers of disease? Completion of the Human Genome Project has encouraged the belief that a major transformation in our understanding of the causes of health and disease is underway, leading to fundamental changes in clinical and public health practice related to the early detection and diagnosis of disease - termed 'personalized medicine'. Though major change may not be imminent, it is clear that we are facing a new era of potentially 'blockbuster' diagnostics, sold at high prices and in relatively large quantities. This is new, and suggests that important shifts may be taking place in the way new diagnostics are discovered, developed and adopted in clinical practice, with a growing role for the industry in research and development, new business strategies within the diagnostics industry in developing and delivering their tests, and new regulatory efforts by governments aimed at managing test adoption. Increased industry involvement may enhance the capacity to develop and validate new tests and bring them to the clinic, but it may also encourage overly aggressive marketing of tests with limited value at unsustainable prices. To date, changes have happened in ad hoc ways, so sustained research is needed to guide public policy in supporting the development and adoption of valuable diagnostics whilst guarding against poor quality tests. Using a comparative approach focused on Canada, the US and UK, we will explore discovery, development and adoption processes for novel molecular tests in three clinical areas: colorectal cancer, lung cancer and the detection of fetal anomalies. Because the potential to detect disease early holds particular promise for both public health and industry, we focus our analysis on medical screening.