Course Description

Diagnostics are indispensable for clinical management and can reduce late-stage health care spending. Accurate diagnostic tests are the cornerstone of global health programs, but they need to be reviewed and cleared or approved by regulatory authorities before they can be used. We review domestic and global regulatory oversight and explore how tests are marketed around the world. Students will learn about the challenges to innovation generalizability, steps in design and development, technical requirements and clinical validity and utility, and reimbursement.

The course features guest lecturers from diagnostic laboratories and manufacturers in the Bay Area. Topics include: regulatory pathways, risk stratification, changing regulatory landscape, performance metrics, common mistakes to be avoided, appropriate statistics, and strategies to bring a test from lab bench to clinical practice. Current issues such as oversight of laboratory-developed tests (LDTs) and “In Vitro Devices Regulation” in the European Union will be addressed. This highly interactive course is based on discussions of assigned readings, presentations by course instructors and/or guests from diagnostic industry in the Bay Area, online discussion forums, and written “peer-review” style critiques of published articles.