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FDA-approved companion diagnostic

PD-L1 IHC 28-8 pharmDx

Qualitative IHC assay using rabbit monoclonal anti–PD-L1 (clone 28-8) to assess 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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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
P150025/
Supplements
S013
Manufacturer
Dako North America, Inc. (Agilent Technologies, Inc.)
Approval date
May 15, 2020
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 28-8 pharmDx is an FDA-approved, qualitative immunohistochemical assay that uses monoclonal rabbit anti–PD-L1, clone 28-8, to detect PD-L1 protein in FFPE tumor tissue. Using the EnVision FLEX system on the Autostainer Link 48, it reports the percentage of tumor cells with membrane staining to classify PD-L1 expression and support PD-1/PD-L1–directed treatment decisions.

Where this test fits

IndicationBiomarkerBiomarker detailsTherapy (Select a therapy to open its FDA-approved testing pathway)
Non-Small Cell Lung Cancer (NSCLC)PD-L1protein expression (tumor cell staining ≥1%)OPDIVO + YERVOY

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 28-8 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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