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Dako PD-L1 IHC 22C3 pharmDx e-Learning Program

Are you ready to assess PD-L1 expression for KEYTRUDA eligibility?

The PD-L1/PD-1 pathway is a new target for new treatments. Get educated on how to evaluate and score PD-L1 expression using PD-L1 IHC 22C3 pharmDx.

The PD-LI IHC 22C3 pharmDx interpretation training program provides education that may help you accurately evaluate and score PD-L1 expression in patients with NSCLC for KEYTRUDA eligibility.

The 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 images for PD-L1 expression
  • Recognize confounding considerations that affect PD-L1 scoring
  • Score images for PD-L1 expression across a variety of patient samples

1. PD-L1 IHC 22C3 pharmDx - Package Insert

2. KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. See the KEYTRUDA product label for expression cutoff values guiding therapy in specific clinical circumstances.

3. Herbst RS, Baas P, Kim DW, Felip E, Pérez-Gracia JL, Han JY et al. Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial. Lancet 2016;387(10027):1540-50.

4. Reck M, Rodríguez-Abreu D, Robinson AG, Hui R, Csőszi T, Fülöp A et al. Pembrolizumab versus chemotherapy for PD-L1-positive non-small-cell lung cancer. NEJM 2016. DOI: 10.1056/NEJMoa1606774.

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) non-small cell lung cancer (NSCLC) and gastric or gastroesophageal junction (GEJ) adenocarcinoma using EnVision FLEX visualization system on Autostainer Link 48.

Non-Small Cell Lung Cancer (NSCLC)

PD-L1 protein expression in NSCLC is determined by using Tumor Proportion Score (TPS), which is the percentage of viable tumor cells showing partial or complete membrane staining at any intensity. The specimen should be considered to have PD-L1 expression if TPS ≥ 1% and high PD-L1 expression if TPS ≥ 50%.

PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying NSCLC patients for treatment with KEYTRUDA® (pembrolizumab). See the KEYTRUDA® product label for expression cutoff values guiding therapy in specific clinical circumstances.

Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

PD-L1 protein expression in gastric or GEJ adenocarcinoma 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 is ≥ 1.

PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying gastric or GEJ adenocarcinoma patients for treatment with KEYTRUDA®.