Molecular Residual Disease Assay Considerations to Ensure Robust ctDNA Detection

Molecular Residual Disease (MRD) in the context of liquid biospy enables detection of tumor recurrence far sooner than traditional imaging technologies, most often through next generation sequencing (NGS) of cell-free DNA (cfDNA) present in the bloodstream in order to detect circulating tumor DNA (ctDNA). Earlier detection often allows for targeted therapy escalation at an earlier stage of cancer or as a sign of a successful response to treatment allowing for de-escalation of therapy.

While solid tumor molecular profile has well-established practices for assay development and validation, liquid biopsy testing has unique concers, especially in the context of MRD testing. Broadly speaking there are two types of MRD assay, tumor-informed and tumor agnostic ctDNA assays. This talk will explain the high-level technical differences between these two types of assays and before highlighting key considerations for assay development and analytic validation of each type of assay. 

Learning Objectives:

1. Understand the difference between tumor-informed and tumor-naive MRD testing at a high level

2. Understand current thinking about best practices for MRD assay development and analytic validation

3. Identify the role of clinical NGS reference materials in supporting advancements in oncology diagnostics.