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IHC Testing

We offer immunohistochemistry (IHC) testing for PD-L1 as a supplemental test to our portfolio of comprehensive genomic profiling (CGP) tests.

PD-L1 IHC Testing at Foundation Medicine

The results of PD-L1 IHC testing combined with CGP results, including data on tumor mutational burden (TMB) and microsatellite instability (MSI), may help you make more informed treatment decisions regarding use of immunotherapies and enrollment in appropriate clinical trials for your patients. Foundation Medicine offers PD-L1 testing as an optional add-on to a CGP test order. 

PD-L1 Dako 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) tissue from multiple tumor types in accordance with the approved product labeling. 

For tumors with no CDx indication, Foundation Medicine will perform PD-L1 testing using the Dako PD-L1 22C3 PharmDx assay. 

PD-L1 Ventana SP142 is a qualitative immunohistochemical assay using rabbit monoclonal anti-PD-L1 clone SP142 intended for use in the assessment of the PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) tissue in accordance with the approved product labeling. 

For breast cancer cases PD-L1 testing will be performed using the Ventana SP142 assay unless otherwise requested. 

For Urothelial Carcinoma (URC), if PD-L1 testing with the Ventana SP142 clone is preferred, please indicate that preference on the test requisition form, via online ordering, or contact our client services team at +1 888.988.3639 or by email at client.services@foundationmedicine.com

IHC PD-L1 FDA-Approved Companion Diagnostics

FDA-approved CDx

Tumor Type Scoring Method FDA-approved Therapy

Non-Small Cell Lung Cancer (NSCLC)

Tumor Proportion Score (TPS)

Keytruda® (pembrolizumab)

Gastric or Gastroesophageal Junction (GEJ) adenocarcinoma

Combined Positive Score (CPS)

Keytruda® (pembrolizumab)

Cervical Cancer

Combined Positive Score (CPS)

Keytruda® (pembrolizumab)

Urothelial Carcinoma (URC)

Combined Positive Score (CPS)

Keytruda® (pembrolizumab)

Head and Neck Squamous Cell Carcinoma (HNSCC)

Combined Positive Score (CPS)

Keytruda® (pembrolizumab)

Esophageal Squamous Cell Carcinoma (ESCC)

Combined Positive Score (CPS)

Keytruda® (pembrolizumab)

Tumor Type Scoring Method FDA-approved Therapy

Urothelial Carcinoma (URC)

Tumor Cell (TC) Score (%) Tumor-Infiltrating Immune Cell (IC) Score (%)

Tecentriq® (atezolizumab)

Triple Negative Breast Cancer (TNBC)

Tumor-Infiltrating Immune Cell (IC) Score (%)

Tecentriq® (atezolizumab)

Need More Details?

Our client services team is here to help, Monday through Friday 8AM – 8PM EST. 

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