ALS 408
Advanced In Vitro Diagnostics

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.

ALS 320

After completion of this course, students should:

• Be familiar with recent technology developments in the established and emerging areas of the in vitro diagnostics industry
• Be able to evaluate the advantages and technical limitations of different IVD assay formats and devices
• Comprehend general approaches, standard parameters, and statistical methods used to characterize IVD assay and device performance
• 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
• Understand the regulatory framework governing the IVD industry, regulatory constraints and loop-holes that impact new product development, as well as recent changes in the regulation of novel assay formats