ALS 408: Advanced In Vitro Diagnostics
400-level Technical/Business Designations: Technical
Medical Devices and Diagnostics: Required
Pharmaceutical Discovery and Development: Elective
This course covers emerging, high impact, and high growth rate areas of the in vitro diagnostics industry such as novel immunoassay formats, diagnostic applications of flow cytometry, molecular diagnostics and pharmaco-genomics, 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 nano-technology 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 lectures 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.
Reading assignments will be handed out in class and will be available electronically on Sakai.
First year MBS science/engineering curriculum, in particular ALS 320.
Regulation of IVDs
Adoption of new diagnostic tests
Cytometry: fluidics and optics
Cytometry: GLP guidelines
Nucleic acid testing
Multivariate index assays
Point of care diagnostics
Global health: diagnostics in limited resource settings
IVD case studies
After completion of this course, students should:
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.
Class participation and in-class exercises 20%
IVD Case Study - Written Report and Presentation 40%
Current Topics in Clinical Chemistry - Written Report & Presentaion 40%