PD-L1 IHC 22C3 pharmDx Overview

Product Information

Clinical Trial-Proven Assay

Key PD-L1 Testing Benefits

Kit Information

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

Learn more about PD-L1 IHC 22C3 pharmDx in:

Non-small Cell Lung Cancer (NSCLC)

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-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

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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) non-small cell lung cancer (NSCLC) and melanoma tissue using EnVision FLEX visualization system on Autostainer Link 48.

Non-Small Cell Lung Cancer (NSCLC) PD-L1 protein expression 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.

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.

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.

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