PD-L1 22C3 FDA (KEYTRUDA®) for HNSCC (Head & Neck)

Code

APH-PDHP-01AX

Test

Active-Compendium

88360x1

Clinical

Oncology,Pathology

Preferred specimen (FFPE block): 
A formalin-fixed, paraffin-embedded (FFPE) tissue block is the preferred specimen type. Use 10% NBF fixative; do not use zinc or mercury fixatives. 

If submitting slides (instead of a block): 
Submit the following. All slides cut at 4-5 microns. Please use positively-charged slides and 10% NBF fixative. 
H&E slide: One (1) unbaked, unstained slide for H&E staining (required) 
Cut Slides: Two (2) positively charged unstained slides for each IHC test/antibody ordered 

PD-L1 22C3 evaluation: 
Tissue submitted must have >100 viable tumor cells present. 

Specimen identification: 
Block and slide identifiers should be clearly written and match exactly with the specimen ID and specimen labeling as noted on the requisition.

Solid Tumors

Upper Aerodigestive tract

Mon, 01/13/2025 - 12:00

Wed, 04/01/2026 - 12:00

Immunohistochemistry (IHC)

Global

Tech Only

Flag Active

True

Orderable Test Description

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 using EnVision FLEX visualization system on Autostainer Link 48. PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying HNSCC patients for treatment with KEYTRUDA® (pembrolizumab). KEYTRUDA® is approved for use in some HNSCC patients whose tumors express PD-L1 with Combined Positive Score (CPS) 1. For other tumor types with approved indications for this test, please search our Test Menu for 22C3 to see available options.

Orderable Turn Around Time

1-2 Days

Keywords

PD-L1

PD-L1 SP142 FDA (TECENTRIQ®) for NSCLC

Meta Description

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 using EnVision FLEX visualization system on Autostainer Link 48.

Orderable Biomarkers

PD-L1

NY Approved

True

Orderable Biomarkers JSON

{"Immunohistochemistry (IHC)": {"Expression": ["PD-L1"]}}

Keywords string

PD-L1, PD-L1 SP142 FDA (TECENTRIQ®) for NSCLC, SP142, FDA, TECENTRIQ, NSCLC PD-L1 22C3 FDA (KEYTRUDA®) for HNSCC (Head & Neck)

Title URL

pd-l1-22c3-fda-keytruda-for-hnscc-head-neck