PD-L1 22C3 FDA (KEYTRUDA®) for TNBC (Breast)

Code

APH-PLTP-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 for H&E staining (required) and two to three (2-3) positively charged unstained slides (all cut at 4-5 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

Breast

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) triple-negative breast cancer (TNBC) tissue using EnVision FLEX visualization system on Autostainer Link 48. This test is indicated as an aid in identifying TNBC patients for treatment with KEYTRUDA® (pembrolizumab). Tissues with PD-L1 Combined Positive Score (CPS) ≥10 are considered positive. Stain-only (tech-only) testing is available to clients who have completed the test kit manufacturers online interpretation training. All PD-L1 IHC test options may be viewed here.</p>

Orderable Turn Around Time

1-2 Days

Keywords

PDL1

triple neg

triple negative breast cancer

Meta Description

<p>PD-L1 22C3 FDA (KEYTRUDA®) for TNBC is a companion diagnostic to identify certain triple-negative breast cancer patients for treatment with KEYTRUDA® and chemotherapy.</p>

Orderable Biomarkers

PD-L1

NY Approved

True

Orderable Biomarkers JSON

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

Keywords string

PDL1, triple neg, triple negative breast cancer, HER2-, HR-, ER-, PR-, PgR-, triple-neg, PD1, PD L1, CDx, cdx PD-L1 22C3 FDA (KEYTRUDA®) for TNBC (Breast)

Title URL

pd-l1-22c3-fda-keytruda-for-tnbc-breast

TAT Details

Global: 2 Days
Tech-Only (stain only): 24 Hours

Storage and transportation

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.