Code
APH-CLAP-01AX
Test
Active-Compendium
88360x1
Clinical
Oncology,Pathology
<b>Preferred specimen (FFPE block):</b><br>
A formalin-fixed, paraffin-embedded (FFPE) tissue block is the preferred specimen type. Use 10% NBF fixative; do not use zinc or mercury fixatives.<br>
<b>If submitting slides (instead of a block):</b><br>
Submit the following. All slides cut at 4-5 microns. Please use positively-charged slides and 10% NBF fixative.<br>
<span style="margin-left: 20px;">H&E slide: One (1) unbaked, unstained slide for H&E staining (required)</span><br>
<span style="margin-left: 20px;">Cut Slides: Two (2) positively charged unstained slides for each IHC test/antibody ordered</span><br>
<b>Specimen adequacy:</b><br>
Tissue submitted must have >100 viable tumor cells present.<br>
<b>Specimen identification:</b><br>
Block and slide identifiers should be clearly written and match exactly with the specimen ID and specimen labeling as noted on the requisition.
A formalin-fixed, paraffin-embedded (FFPE) tissue block is the preferred specimen type. Use 10% NBF fixative; do not use zinc or mercury fixatives.<br>
<b>If submitting slides (instead of a block):</b><br>
Submit the following. All slides cut at 4-5 microns. Please use positively-charged slides and 10% NBF fixative.<br>
<span style="margin-left: 20px;">H&E slide: One (1) unbaked, unstained slide for H&E staining (required)</span><br>
<span style="margin-left: 20px;">Cut Slides: Two (2) positively charged unstained slides for each IHC test/antibody ordered</span><br>
<b>Specimen adequacy:</b><br>
Tissue submitted must have >100 viable tumor cells present.<br>
<b>Specimen identification:</b><br>
Block and slide identifiers should be clearly written and match exactly with the specimen ID and specimen labeling as noted on the requisition.
Flag Active
True
Orderable Test Description
<p>The VENTANA Claudin‑18 (43‑14A) RxDx Assay is an FDA‑approved qualitative immunohistochemical (IHC) assay that uses a mouse monoclonal anti‑Claudin‑18 antibody. The assay is intended for the assessment of Claudin‑18 protein expression, encoded by the CLDN18 gene, in formalin‑fixed, paraffin‑embedded (FFPE) gastric cancer tissue and is performed on the VENTANA BenchMark ULTRA instrument.<br><br>
Claudin‑18 testing is indicated as an aid in identifying patients with <b>Gastric Adenocarcinoma</b>, including <b>Gastroesophageal junction (GEJ) Adenocarcinoma</b>. Tumors demonstrating Claudin‑18 expression in ≥75% of tumor cells with 2+ and/or 3+ staining intensity may be eligible for treatment with VYLOY® (zolbetuximab).</p>
Claudin‑18 testing is indicated as an aid in identifying patients with <b>Gastric Adenocarcinoma</b>, including <b>Gastroesophageal junction (GEJ) Adenocarcinoma</b>. Tumors demonstrating Claudin‑18 expression in ≥75% of tumor cells with 2+ and/or 3+ staining intensity may be eligible for treatment with VYLOY® (zolbetuximab).</p>
Orderable Turn Around Time
1-2 Days
Orderable Biomarkers
NY Approved
True
Orderable Biomarkers JSON
{"Immunohistochemistry (IHC)": {"Expression": ["Claudin-18", "CLDN18"]}}
Keywords string
Claudin 18 IHC, Claudin 18 CDx, CLDN 18, CLDN 18.2, Gastric Adenocarcinoma, GEJ Claudin 18 FDA (VYLOY®) for Gastric/GEJ Adenocarcinoma
Title URL
claudin-18-fda-vyloy-for-gastric-gej-adenocarcinoma
TAT Details
Global: 2 Days
Tech-Only (stain only): 24 Hours
Storage and transportation
Slides may be stored at room temperature; transport with cold pack, making sure cold pack is not in direct contact with specimen.
NYS Clients: Please provide Date and Time of Collection.