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FDA-approved companion diagnostic

PD-L1 IHC 22C3 pharmDx

Qualitative IHC assay using monoclonal anti–PD-L1 (clone 22C3) to detect PD-L1 protein expression in FFPE tumors and support immunotherapy treatment decisions.

IVD-developed CDxMethod: IHCSpecimen: Tissue (FFPE)Biomarker: PD-L1 protein expression
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Casandra.ai provides a unified ordering experience so you can request this test directly from the performing lab, without changing your workflow.

Ordering is available where Casandra has an active integration with the performing lab. Labs that offer this test can connect with us to enable digital ordering.

About this test

FDA approval details
PMA number
P150013
Supplements
S009, S014, S016, S020, S021, S027
Manufacturer
Dako North America, Inc. (Agilent Technologies, Inc.)
Approval date
October 2, 2015
Test specifications
Methodology
IHC
Specimen
Tissue (FFPE)
Report format
Comprehensive report PDF
Turnaround (typical)
Not specified
Biomarker(s)
PD-L1 protein expression
What this test is

PD-L1 IHC 22C3 pharmDx is an FDA-approved, qualitative immunohistochemical assay that uses monoclonal mouse anti–PD-L1 (clone 22C3) to detect PD-L1 protein in formalin-fixed, paraffin-embedded tumor tissue. Performed with an automated staining system and standardized scoring (e.g., TPS, CPS), it classifies PD-L1 expression status to help identify patients who may be candidates for PD-1/PD-L1–directed therapies.

Where this test fits

IndicationBiomarkerBiomarker detailsTherapy (Select a therapy to open its FDA-approved testing pathway)
Cervical CancerPD-L1protein expressionKEYTRUDA
Esophageal Squamous Cell Carcinoma (ESCC)PD-L1protein expressionKEYTRUDA
Gastric or Gastroesophageal Junction (GEJ) AdenocarcinomaPD-L1protein expressionKEYTRUDA
Head and Neck Squamous Cell Carcinoma (HNSCC)PD-L1protein expressionKEYTRUDA
Non-Small Cell Lung Cancer (NSCLC)PD-L1protein expressionKEYTRUDA
protein expression [Tumor Proportion Score (TPS) ≥ 50%]LIBTAYO
Triple-Negative Breast Cancer (TNBC)PD-L1protein expressionKEYTRUDA

IVD Manufacturer

Dako North America, Inc. (Agilent Technologies, Inc.)

Agilent Technologies Inc. (NYSE: A) is a global leader in analytical and clinical laboratory technologies, delivering insights and innovation that help our customers bring great science to life. Agilent’s full range of solutions includes instruments, software, services, and expertise that provide trusted answers to our customers' most challenging questions. The company generated revenue of $6.95 billion in fiscal year 2025 and employs approximately 18,000 people worldwide. Information about Agilent is available at www.agilent.com. To receive the latest Agilent news, subscribe to the Agilent Newsroom. Follow Agilent on LinkedIn and Facebook.

Order this test

If your organization is connected to Casandra, you can place an electronic order forPD-L1 IHC 22C3 pharmDx directly from your existing workflow.

Casandra connects providers, labs, and sponsored programs so that companion diagnostics can be ordered consistently and documented cleanly, regardless of which system you start from.

CDxTests.com is an informational resource for providers. Always refer to the official FDA labeling and laboratory documentation when making treatment decisions.

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