PD-L1 28-8 (OPDIVO®) for Gastric/GEJ/EAC
Also known as: PD-L1 28-8 (OPDIVO®) for Gastric/GEJ/Esophageal Adenocarcinoma
Companion Diagnostic
PD-L1 28-8 (OPDIVO®) for Gastric/GEJ/EAC is an FDA-approved companion diagnostic used to help identify patients who may be eligible for targeted therapies.
Use
PD‑L1 IHC 28‑8 pharmDx is used to detect PD‑L1 protein expression via immunohistochemistry in formalin‑fixed, paraffin‑embedded gastric carcinoma, gastroesophageal junction carcinoma (GEJ), and esophageal adenocarcinoma (EAC) tissues. While not FDA‑approved for these tumor types, data from the CHECKMATE 649 study demonstrated that nivolumab (OPDIVO®) combined with chemotherapy significantly improved overall survival and progression‑free survival compared with chemotherapy alone. PD‑L1 Combined Positive Score (CPS) ≥ 5 indicates PD‑L1 expression in tissue samples.
Special Instructions
Not provided.
Limitations
Not provided.
FDA ApprovedNew York ApprovedCompanion Diagnostic
Methodology
Immunoassay (IHC)
Biomarkers
PD‑L1
Protein
Result Turnaround Time
1-2 days
Related Documents
For more information, please review the documents below
Specimen
Tissue (FFPE)
Volume
Not provided
Minimum Volume
Not provided
Collection Instructions
Preferred: FFPE tissue block or one unbaked, unstained slide for H&E staining (required) plus two to three positively charged unstained slides, all cut at 4‑5 microns.
Storage Instructions
Use cold pack for transport (not in direct contact with specimen).