This course covers emerging, high impact, and high growth rate areas of the in vitro diagnostics (IVD) industry such as novel immunoassay formats, diagnostic applications of flow cytometry, molecular diagnostics and pharmacogenomics, personalized medicine and drug diagnostic co-development, point of care diagnostics in developed countries and in global health/limited resource settings, as well as micro-fluidics and nanotechnology in diagnostics. Students will acquire in depth knowledge of technical aspects as well as an overview of relevant FDA regulatory concerns and market barriers to the adoption of new technologies. The course consists of discussions current issues in the IVD market place supplemented by assigned readings and in class exercises. The last six lectures are dedicated to case studies on IVD applications to particular diseases with student presentations.
After completion of this course, students should: