The Dako PD-L1 IHC 22C3 pharmDx Interpretation Training Program

PD-L1 is a proven biomarker for patient response to KEYTRUDA® (pembrolizumab) in
triple-negative breast cancer (TNBC)
(PD-L1 IHC 22C3 pharmDx [Instructions for Use], 2020). Review how to evaluate and score PD-L1 expression using PD-L1 IHC 22C3 pharmDx and the Combined Positive Score (CPS).

The Dako PD-L1 IHC 22C3 pharmDx Interpretation Training Program uses in-depth content, engaging activities, and comprehensive cases to help you confidently:

  • Understand the core principles of PD-L1 pathology
  • Learn the process for evaluating stained specimens for PD-L1 expression
  • Recognize confounding considerations that affect PD-L1 interpretation
  • Score images for PD-L1 expression across a variety of patient samples

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Intended Use For in vitro diagnostic 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) triple-negative breast cancer (TNBC) tissue using EnVision FLEX visualization system on Autostainer Link 48.

Triple-Negative Breast Cancer (TNBC)

PD-L1 protein expression in TNBC is determined by using Combined Positive Score (CPS), which is the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100. The specimen should be considered to have PD-L1 expression if CPS ≥ 10.

PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying TNBC patients for treatment with KEYTRUDA® (pembrolizumab).

For descriptions of the intended use in other indications, please refer to the current version of the Instructions for Use (IFU) for PD-L1 IHC 22C3 pharmDx, Code SK006.

For countries outside of the United States, see the local KEYTRUDA product label for approved indications and expression cutoff values to guide therapy.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc