Home·Explore by biomarker·Claudin 18 (CLDN18)

Claudin 18 (CLDN18)

Biomarker

CLDN18 is a tight junction protein expressed in gastric and other epithelial tissues. Aberrant expression, particularly CLDN18.2, is a validated target for antibody-based therapies in gastric and gastroesophageal cancers.

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 Claudin 18 (CLDN18) is defined directly in the indication labeling.

IndicationBiomarker criteriaTherapies
Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Solid Tumor · Stomach/GEJ
  • Claudin 18 (CLDN18) protein expression (≥75% viable tumor cells (% TC) staining)
Tumor-agnostic approvals

Approvals defined at the solid tumor level where Claudin 18 (CLDN18) is part of the eligibility criteria.

No tumor-agnostic approvals are currently mapped for this biomarker.

Tests that measure this biomarker

These assays report Claudin 18 (CLDN18) as part of their validated menu. In many cases they are identified in FDA labeling as acceptable companion diagnostics for specific approvals.

Test
Ventana CLDN18 (43-14A) RxDx Assay
Ventana Medical Systems, Inc.
Method
IHC
Specimen
Tissue (FFPE)

Reports Claudin 18 (CLDN18) as part of its biomarker panel.

This view is scoped to Claudin 18 (CLDN18). You can also see how it compares with other biomarkers and indications on the Know Your Companions™ map.
Claudin 18 (CLDN18) Biomarker | CDxTests.com | CDx Tests