- Cancer Care Team
Cancer Care Team
To deliver optimal patient outcomesProducts and Services
Cancer Type
Supplies & Tools
Scientific Focus
- Biopharma Partners
- Patients
- Education & Events
- Login
- Contact Us
Products and Services
Cancer Type
Supplies & Tools
Scientific Focus
3 days
This assay is indicated as an aid in identifying patients with gastric or gastro-esophageal junction (GEJ) adenocarcinoma who may be eligible for treatment with VYLOY™ (zolbetuximab) in accordance with the approved therapeutic product labeling.
Note: This test number is used for tracking oncology IHC specimens to the laboratory. Bill codes will be added when testing is complete, based on the processes performed in the laboratory.
Decalcification and improper fixation may negatively affect results.
Immunohistochemistry
Shitara K, Lordick F, Bang YJ, et al. Zobetuzimab plus mFOLFOX6 in patients with claudin-18 isoform 2 positive, HER2-negative, untreated, locally advanced unresectable or metastatic gastric or gasatrooesophageal junction adenocarcinoma (SPOTLIGHT): a multicentre, radomised, double-blind, phase 3 trial. Lancet. 2023 May 20;401(10389):1655-1668. PubMed 37068504
VENTANA CLDN18 (43-14A) RxDXAssay [package insert]. Ventana Medical Systems, Inc. Tuscon, AZ; 2024.
Information on collection, storage, and volume
Formalin fixed paraffin-embedded (FFPE) tissue block or slides
One paraffin block or five air-dried unstained slides sectioned at 4-5 microns, no more than 45 days in age
At least three unstained slides sectioned at 4-5 microns
Paraffin block or unstained positive charged slides
Tumor types other than gastric/gastro-esophageal adenocarcinoma; improper fixation; freezing; thawing; washing; heating; sectioning or contamination with other tissue; slides sectioned greater than 45 days prior to test request
Collect specimen on paraffin block or unstained slides sectioned off no more than 45 days in age.
The recommended fixative is 10% neutral buffered formalin for 24 hours with a range from six to 48 hours fixation time. Slides should be cut at 3-5 micron thickness and mounted onto positively charged slides. It is recommended that slides are stained shortly after slide preparation, as antigenicity of cut tissue sections may diminish.
Find more tests related to this one.