PTEN
Biomarker
PTEN is a biomarker used in companion diagnostic testing.
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 PTEN is defined directly in the indication labeling.
| Indication | Biomarker criteria | Therapies |
|---|---|---|
Metastatic hormone-sensitive prostate cancer (mHSPC) Solid Tumor |
|
Tumor-agnostic approvals
Approvals defined at the solid tumor level where PTEN is part of the eligibility criteria.
No tumor-agnostic approvals are currently mapped for this biomarker.
Tests that measure this biomarker
These assays report PTEN as part of their validated menu. In many cases they are identified in FDA labeling as acceptable companion diagnostics for specific approvals.
Test
Ventana PTEN (SP218) RxDx Assay
Ventana Medical Systems, Inc.
Method
IHC
Specimen
Tissue (FFPE)
Reports PTEN as part of its biomarker panel.
1 approvalView test profile →