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

Code

APH-PDHP-01AX

Test

Active-Compendium

88360x1

Clinical

Oncology,Pathology

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) 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 for each test/antibody ordered.
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.

Solid Tumors

Upper Aerodigestive tract

Mon, 01/13/2025 - 12:00

Wed, 01/28/2026 - 12:00

Immunohistochemistry (IHC)

Global

Tech Only

Flag Active

True

Orderable Test Description

<p>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.</p>

Orderable Turn Around Time

1-2 Days

Keywords

PD-L1

PD-L1 SP142 FDA (TECENTRIQ®) for NSCLC

Meta Description

<p>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.</p>

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