Diagnostics in Infectious Diseases: Development, Regulatory and Implementation Challenges

2 credits · Graduate

Diagnostics are indispensable for clinical management and accurate diagnostic tests are the cornerstone of global health programs, but they need to be reviewed and cleared by regulatory authorities before they can be used. Class reviews domestic and global regulatory oversight and explores 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/utility, and reimbursement. 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.