Course Detail

This course covers current trends and recent technology developments of the in vitro diagnostics industry. We will discuss selected topics in emerging, high impact, and high growth rate areas. Students will acquire an overview of novel assay formats, detection principles, instrumentation, and data analysis tools, and will learn to critically evaluate the utility of different diagnostic assays and devices for specific clinical applications. The course consists of lectures supplemented by assigned readings, computer exercises, in addition to student presentations. The course will also include two short labs.

Course Materials
Reading assignments will be handed out in class and will be available in electronic format on Sakai.

1. be familiar with recent technology developments in the established and emerging areas of the in vitro diagnostics industry.
2. be able to evaluate the advantages and technical limitations of different IVD assay formats and devices.
3. comprehend general approaches, standard parameters, and statistical methods used to characterize IVD assay and device performance.
4. have in-depth knowledge acquired through independent investigation of one emerging, high growth or high impact area of the IVD industry, both from a technical and business perspective. Be able to present this knowledge in oral and written form.
5. understand the regulatory framework governing the IVD industry, regulatory constrains and loop-holes that impact new product development, as well as recent changes in the regulation of novel assay formats.
6. be able to independently conduct a simple immunoassay and molecular diagnostic assay in the lab, and to evaluate the resulting data.