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PD-L1 IHC 22C3 pharmDx Overview

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For PD-L1 testing, the choice is clear: use PD-L1 IHC 22C3 pharmDx, the one assay clinical trial-proven with KEYTRUDA
  • With indications across a wide range of cancer types, oncologists are increasingly selecting patients for treatment with KEYTRUDA
  • PD-L1 IHC 22C3 pharmDx is the clinically relevant option when considering patients for treatment with KEYTRUDA
PD-L1 IHC 22C3 pharmDx delivers high specificity and sensitivity

High specificity for accurate clinical results

High sensitivity for precise PD-L1 detection

  • Assessment of PD-L1 expression in NSCLC demonstrated staining across the dynamic range of TPS 0–100% and 0–3+ staining intensities

The stains above are of NSCLC specimens stained with PD-L1 IHC 22C3 pharmDx.

PD-L1 IHC 22C3 pharmDx delivers repeatable and reproducible results in ONE pre-validated assay to elevate your diagnostic confidence
  • Agilent performed rigorous repeatability testing to ensure reliable results
  • 100% overall agreement across inter-instrument, inter-operator, inter-day, and intra-run tests*
  • Reproducibility testing performed at three external testing sites demonstrated > 85% overall agreement across all tests*
  • Inter-site, intra-site, inter-observer, and intra-observer tests were all performed
  • PD-L1 IHC 22C3 pharmDx comes pre-validated, including validated scoring guidelines and on-site product demonstrations
  • All necessary components for a complete staining run are validated together and included in each kit

*Overall agreement is based on average negative and average positive agreements. Tests were performed using NSCLC tissue.

Efficiency and convenience in an all-in-ONE kit
  • PD-L1 IHC 22C3 pharmDx is a standardized IHC assay with all necessary components for 50 tests in one kit
  • Designed for use on Autostainer Link 48, which comes preprogrammed with a validated staining protocol in the DakoLink software
Want to hear more about PD-L1 IHC 22C3 pharmDx? Send us an email and we'll get back to you ...or find more contact information

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), gastric or gastroesophageal junction (GEJ) adenocarcinoma, and cervical cancer tissues 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 ≥ 1.

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

Cervical Cancer PD-L1 protein expression in cervical cancer 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 ≥ 1.

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

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

References: 1. PD-L1 IHC 22C3 pharmDx [package insert]. Carpinteria, CA: Dako, Agilent Pathology Solutions; 2017. 2. Keytruda [package insert]. Hoddesdon, UK: Merck Sharp & Dohme Limited; 2017. 3. Garon EB, Rizvi NA, Hui R, et al. Pembrolizumab for the treatment of non-small-cell lung cancer. N Engl J Med. 2015;372(21):2018-2028. 4. Herbst RS, Baas P, Kim DW, 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):1540-1550. 5. Reck M, Rodríguez-abreu D, Robinson AG, et al. Pembrolizumab versus chemotherapy for PD-L1-positive non-small-cell lung cancer. N Engl J Med. 2016;375(19):1823-1833. 6. Roach C, Zhang N, Corigliano E, et al. Development of a companion diagnostic PD-L1 immunohistochemistry assay for pembrolizumab therapy in non-small-cell lung cancer. Appl Immunohistochem Mol Morphol. 2016;24:392-397.