Claudin 18 FDA (VYLOY®) for Gastric/GEJ Adenocarcinoma
Use
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, indicated as an aid in identifying patients with Gastric Adenocarcinoma 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).
Special Instructions
Not provided.
Limitations
Not provided.
FDA ApprovedNew York Approved
Methodology
Immunoassay (IHC)
Biomarkers
CLDN18
Protein
Result Turnaround Time
1-2 days
Related Documents
For more information, please review the documents below
Specimen
Tissue (FFPE)
Volume
1 paraffin block or 2–3 unstained slides
Minimum Volume
Not provided
Container
Positively charged slides or block
Collection Instructions
1 block sent with cold pack; no zinc or mercury fixatives; H&E: 1 unstained slide cut at 4‑5 microns; 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; slides in 10% NBF
Storage Instructions
Use cold pack for transport, not in direct contact with specimen; NYS clients provide date and time of collection