PD-L1 22C3 FDA (KEYTRUDA®) for ESCC (Esophageal Squamous Cell Carcinoma)
Companion Diagnostic
PD-L1 22C3 FDA (KEYTRUDA®) for ESCC (Esophageal Squamous Cell Carcinoma) is an FDA-approved companion diagnostic used to help identify patients who may be eligible for targeted therapies.
Use
PD-L1 IHC 22C3 pharmDx is a qualitative immunohistochemical assay using Monoclonal Mouse Anti‑PD‑L1, Clone 22C3 intended for use in the detection of PD‑L1 protein in formalin‑fixed, paraffin‑embedded (FFPE) esophageal squamous cell carcinoma (ESCC) tissue. It is indicated as an aid in identifying ESCC patients for treatment with KEYTRUDA® (pembrolizumab), which is approved for use in some ESCC patients whose tumors express PD‑L1 with Combined Positive Score (CPS) ≥10.
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
A formalin‑fixed, paraffin‑embedded (FFPE) tissue block is preferred specimen type or one unbaked, unstained slide cut at 4‑5 microns for H&E staining (required) and two to three (2‑3) positively charged unstained slides cut at 3‑4 microns. Tissue must have 100 viable tumor cells present.
Storage Instructions
Use cold pack for transport, making sure cold pack is not in direct contact with specimen. NYS clients please provide date and time of Collection.