Claudin 18 FDA (VYLOY®) for Gastric/GEJ Adenocarcinoma

Code

APH-CLAP-01AX

Test

Active-Compendium

88360x1

Clinical

Oncology,Pathology

Paraffin Block: 1 Block sent with a cold pack. No zinc or mercury fixatives. H&E: 1 unstained slide cut at 4-5 microns required. Cut Slides: 2 to 3 unstained slides cut at 4-5 microns. 1 slide per antibody/probe ordered. >100 viable tumor cells per probe set. Positively charged slides in 10% NBF. No zinc or mercury fixatives.

Solid Tumors

Gastroesophageal

GIST/Soft Tissue

Mon, 01/13/2025 - 12:00

Wed, 01/22/2025 - 12:00

Immunohistochemistry (IHC)

Global

Technical Only

Flag Active

True

Orderable Test Description

<p>The VENTANA Claudin 18 (43-14A) RxDx Assay is an FDA-approved qualitative immunohistochemical assay using a mouse monoclonal anti-Claudin 18 antibody intended for use in the assessment of Claudin 18 protein in formalin-fixed, paraffin-embedded (FFPE) gastric cancer tissue on a VENTANA BenchMark ULTRA instrument. Claudin 18 is indicated as an aid in identifying patients with Gastric Adenocarinoma including Gastroesophageal Junction (GEJ). Tumors that have Claudin 18 expression in ≥75% of tumor cells staining at 2+ and/or 3+ intensity may be eligible for treatment with VYLOY® (zolbetuximab).</p>

Orderable Turn Around Time

Global: 2 Day, Tech-Only (stain only): 1 Day

Keywords

Gastric Adenocarcinoma

GEJ

Meta Description

<p>Claudin 18 is an FDA-approved IHC assay intended for use in the assessment of Claudin 18 protein in Gastric/GEJ Adenocarcinoma cancer tissue.</p>

Extra Note