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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 for clinical customers.

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 for clinical customers.

Dako 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) tissue from multiple tumor types in accordance with the approved product labeling.1

Dako PD-L1 IHC 28-8 pharmDx is a qualitative immunohistochemical assay using monoclonal rabbit anti-PD-L1, clone 28-8 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.2

Ventana PD-L1 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.3

PD-L1 IHC FDA-Approved Companion Diagnostics

Tumor Type

Clone Offered Scoring Method FDA-Approved Therapy

Dako 22C3

Tumor Proportion Score (TPS)

Keytruda® (pembrolizumab)

Dako 28-8

Tumor Cell Expression (%)

Opdivo® (nivolumab) in combination with Yervoy® (ipilimumab)

Ventana SP142

Tumor Cell (TC) and Immune Cell (IC) Score

Tecentriq® (atezolizumab)

Clone Offered Scoring Method FDA-Approved Therapy

Dako 22C3

Combined Positive Score (CPS)

Keytruda® (pembrolizumab)

Clone Offered Scoring Method FDA-Approved Therapy

Dako 22C3

Combined Positive Score (CPS)

Keytruda® (pembrolizumab)

Clone Offered Scoring Method FDA-Approved Therapy

Dako 22C3

Combined Positive Score (CPS)

Keytruda® (pembrolizumab)

Ventana SP142

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

Tecentriq® (atezolizumab)

Clone Offered Scoring Method FDA-Approved Therapy

Dako 22C3

Combined Positive Score (CPS)

Keytruda® (pembrolizumab)

Clone Offered Scoring Method FDA-Approved Therapy

Dako 22C3

Combined Positive Score (CPS)

Keytruda® (pembrolizumab)

Clone Offered Scoring Method FDA-Approved Therapy

Dako 22C3

Combined Positive Score (CPS)

Keytruda® (pembrolizumab)

Ventana SP142

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

Tecentriq® (atezolizumab)

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Additional Notes

1 Dako PD-L1 IHC 22C3 pharmDx. Package insert. Agilent Technologies, Inc. 2019. https://www.accessdata.fda.gov/cdrh_docs/pdf15/P150013S014C.pdf

2 Dako PD-L1 IHC 28-8 pharmDx. Package insert. Agilent Technologies, Inc.  2017. https://www.accessdata.fda.gov/cdrh_docs/pdf15/P150025S013C.pdf

3 Ventana® PD-L1 SP142. Package insert. Roche Diagnostics GmbH. 2019. https://www.accessdata.fda.gov/cdrh_docs/pdf16/p160002s009c.pdf

Dako® is a registered trademark of Agilent Technologies, Inc. Ventana® is a registered trademark of Roche Diagnostics GmbH.