ABOUT BOOK

As discussed in this chapter, the commercialization and adoption bottlenecks for these moderately complex diagnostics cannot be overcome by ~technological innovation alone, particularly in the highly regulated and ~payer-limited healthcare and public health markets. Diagnostics, unlike ~other clinical products, is not an intervention but a decision-aid that guides ~the use (or nonuse) of an intervention. It is important that the value proposition ~for any technology-centric innovation in diagnostics include a strong ~link to a gained efficiency in making a specific decision. Any assay developed ~without context to the system, users, decision points, and downstream ~interventions resembles one that is more targeted to the research community, ~rather than clinical care or public health.