TMB
BiomarkerTMB (Tumor Mutational Burden)
Tumor mutational burden reflects the number of mutations within a tumor genome. High TMB may predict response to immune checkpoint inhibitors.
Approvals
1
Indications
1
Therapies
1
Mapped tests
1
Where this biomarker is used
Each approval combines this biomarker with a specific indication and therapy. Select a therapy in the tables below to open its FDA-defined testing pathway.
Indication-specific approvals
Approvals where TMB is defined directly in the indication labeling.
No indication-specific approvals are currently mapped for this biomarker.
Tumor-agnostic approvals
Approvals defined at the solid tumor level where TMB is part of the eligibility criteria.
| Level | Biomarker criteria | Therapies |
|---|---|---|
| Solid Tumors |
|
Tests that measure this biomarker
These assays report TMB as part of their validated menu. In many cases they are identified in FDA labeling as acceptable companion diagnostics for specific approvals.
Test
FoundationOne CDx
Foundation Medicine, Inc.
Method
NGS
Specimen
Tissue (FFPE)
Reports TMB as part of its biomarker panel.
1 approvalView test profile →