This document addresses hybrid personalized molecular residual disease (MRD) testing for oncologic disease management. This personalized testing occurs in a two-step process. The first step involves whole exome sequencing (WES) of the tumor tissue. In the second step,  information about the tumor learned from the WES is used to develop a personalized assay to to detect circulating tumor DNA (ctDNA) that assesses MRD. Commercially available personalized MRD tests include the Signatera™ test (Natera Inc., San Carlos, CA) and the RaDaR™ test (Inivata, Research Triangle Park, NC).

Note: Please see the following related documents for additional information:

• CG-GENE-19 Measurable Residual Disease Assessment in Lymphoid Cancers Using Next Generation Sequencing
• GENE.00052 Whole Genome Sequencing, Whole Exome Sequencing, Gene Panels, and Molecular Profiling
• GENE.00054 Paired DNA and Messenger RNA (mRNA) Genetic Testing to Detect, Diagnose and Manage Cancer

Position Statement

Investigational and Not Medically Necessary:

Oncologic hybrid personalized molecular residual disease (MRD) tests are considered investigational and not medically necessary for all indications.