Short Course - Assay Design and Validation

Tuesday, November 16th from 2:00 - 5:00pm 

Session Description: As next-generation sequencing (NGS) based clinical assays are gaining traction for clinical tumor profiling, it is imperative to design and implement NGS assays in optimal ways in the clinical laboratories. In this short course, faculty will share their experience and expertise in terms of desigining and implementing NGS assays, considerations for validation and approvals, and use of proficiency testing for continous quality control measures.

Learning Objectives:

• Design considerations for DNA based NGS assays for both somatic and germline testing
• Describe FDA clearance pathways for Class II/III devices and requirements
• Describe different validation considerations for both laboratory work and bioinformatics pipelines. Learn why and how proficiency tests (PTs) are useful, and the different kinds of types of PTs (somatic, germline, in-silico)