PD-L1 22C3 FDA (KEYTRUDA®) for HNSCC (Head & Neck)
Also known as: PD-L1, 22C3, KEYTRUDA
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) head and neck squamous cell carcinoma (HNSCC) and certain other tissues. It aids in identifying HNSCC patients for treatment with KEYTRUDA® (pembrolizumab).
Special Instructions
Block and slide identifiers should be clearly written and match exactly with the specimen ID and specimen labeling as noted on the requisition. For PD-L1 22C3 evaluation, tissue submitted must have 100 viable tumor cells present.
Limitations
The test is indicated as an aid in identifying HNSCC patients for treatment with KEYTRUDA®, approved for use in HNSCC patients whose tumors express PD-L1 with Combined Positive Score (CPS) ≥ 1.
FDA ApprovedNew York Approved
Methodology
Immunoassay (IHC)
Biomarkers
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 or unstained slides cut at 3-4 microns for each test/antibody ordered.
Storage Instructions
Use cold pack for transport, ensuring it is not in direct contact with specimen.