ALS 320: Medical Diagnostics
Course Number: ALS 320
Course Name: Medical Diagnostics
Year: First-year
Semester: Fall
No. Units: 1
Faculty/Instructor(s): Angelika Niemz, James C. Osborne
Description
The in vitro diagnostics industry focuses on developing methods for the diagnosis, screening, and monitoring of human diseases based on identification and quantification of small molecules, proteins, oligonucleotides, or of cells and tissues of a certain phenotype. 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 and will enable students to 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, device fabrication, optics, fluid mechanics, and laboratory automation. The course also features aspects of market research, project management, and device regulatory affairs.
Prerequisites
Mandatory for first-year MBS students.
Topics Covered
Overview of the diagnostics industry
Product development for In Vitro Diagnostics
Biomarkers: discovery and validation
Assay development: analytical & clinical validation
Requirements driven engineering design
Detection methods, instrumentation for optical detection
Biomolecular recognition / nucleic acid hybridization
Enzymes in clinical and molecular diagnostics
Heat transfer of thermocycling
Miniaturization and microfabrication
Microfluidics, fluid handling
Laboratory automation
Artifact design
Flow cytometry
Device regulatory affairs
Immunoassays
Clinical chemistry
Molecular diagnostics
Pharmacogenomics
Histology and cytology
Hematology, coagulation
Diabetes monitoring
Learning Objectives
After completing this course, students should be able to:
1.) describe the major diagnostic assay types and their applications
2.) correctly interpret metrics used in bioassay development and validation
3.) assess the technical merit and competitive position of current IVD technologies
4.) develop a preliminary design of a diagnostic device using a requirements driven engineering approach
5.) apply fundamental project management tools to implement an interdisciplinary team-based effort
Grading
Class Participation / In Class Exercises 10%
Individual Assignments 15%
Midterm Exam 25%
Team Project 50%
Required Texts