**CLAUDIN 18.2 IHC BIOMARKER**

**Assay Purpose:**

**D**iagnostic : gastric or gastroesophageal junction (GEJ) adenocarcinoma

**D**rug: Zolbetuximab

**D**iagnostic test: CLDN18.2 Immunohistochemistry (IHC), VENTANA CLDN18 (43-14A) %%RxDx%% assay

Performed on block %%**%%*

**Result:       Positive <color red> **OR** </color> Negative <color red> **OR** </color> Inadequate <color red> **OR** </color> EQUIVOCAL (See Comment)**

**Interpretation**: % membranous tumoral with moderate/strong staining - Negative (< 75%), Positive (>= 75%)

Batch control: **Adequate**; on slide controls: **Adequate**

Disclaimer: Based on the CLDN18.2-positive status, this patient may be eligible for treatment with VYLOY™ (Zolbetuximab)—a CLDN18.2-directed cytolytic antibody—in combination with fluoropyrimidine- and platinum-containing chemotherapy. This therapeutic regimen is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.\\
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Shitara, K., et al. (2023).\\
Zolbetuximab plus mFOLFOX6 in Claudin 18.2–Positive, HER2-Negative, Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (SPOTLIGHT): A Randomized, Double-Blind, Phase 3 Trial. The Lancet, 401(10374), 1655–1668.https:%%//%%doi.org/10.1016/S0140-6736(23)00498-7

Test ID: BMCLAUDIN18

{{:BMCLAUDIN18.docx | ''BMCLAUDIN18''}}