Course Detail

The in vitro diagnostics industry focuses on developing methods for the screening, diagnosis and monitoring of human diseases based on identification and quantification of small molecules, proteins, oligonucleotides, or of cells and tissues of a certain phenotype. Related assays and instrumentation are also applied in fundamental research, drug discovery and development, and in quality control of biologics. Developing diagnostic assays, instrumentation and devices requires input from many disciplines such as biochemistry, molecular biology, engineering, physics and computer science.

This course provides an overview of the in vitro diagnostics industry.  Students will acquire the basic knowledge and skills needed to understand and ultimately design diagnostic assays and devices.  Students will become familiar with the fundamentals of biomolecular recognition, assay development, engineering design, artifact fabrication, optics, fluid mechanics, laboratory automation, and with the regulatory framework for medical devices.

Overview of the diagnostics industry
Biomarkers
Biomolecular recognition
Nucleic acid hybridization
Enzymes in molecular diagnostics
Heat transfer of thermocycling
Artifact design
Miniaturization and microfabrication
Microfluidics and fluid handling
Optical detection methods and instrumentation
Immunoassays
Clinical chemistry, hematology
Flow cytometry
Molecular diagnostics
Pharmacogenomics and theranostics
Diabetes monitoring
Nanotechnology in diagnostics
Laboratory automation
Point of care testing
Device regulatory affairs
Requirements driven engineering design
Project management

After completing this course, students should

• Know the major diagnostic assay types and their applications
• Understand the fundamentals of bioassay development and validation
• Be able to develop a preliminary design of a diagnostic device using a requirements driven engineering approach
• Be able to identify the regulatory processes required for the approval of different types of diagnostic assays and devices
• Be familiar with project management fundamentals and tools

Class participation          10%

Homework and Lab Reports          30%

Group Design Project           40%

Exam                                 20%