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PD-L1 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.

Overview

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 well-informed treatment decisions regarding use of immunotherapies and enrollment in appropriate clinical trials for your patients. Foundation Medicine offers PD-L1 IHC 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

Test Selection

Selecting a PD-L1 IHC Test

Each of the FDA-approved tests above uses its own PD-L1 IHC clone and scoring method, and has specific therapies associated with it. Some tumor types have multiple options for approved clones. For tumor types that do not have an approved PD-L1 indication, we will perform the test indicated on the order.

Use the tables below to help determine the appropriate clone for your patient.

Indications

PD-L1 IHC Clones by Tumor Type available in the United States

Tumor Type

Clone Offered Scoring Method FDA-Approved Therapy

Dako 22C3

Tumor Proportion Score (TPS)

Keytruda® (pembrolizumab), Libtayo® (cemiplimab-rwlc)

Dako 28-8

Tumor Cell Expression (%)

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

Ventana SP142

Tumor Cell (TC) and 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)

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)

Clone Prioritization

Additional Test Selection Information

There are several instances when Foundation Medicine pathology may be required to make a decision about the appropriate test or scoring method for your patient. They include:

  • When no PD-L1 IHC test/clone is selected by the ordering physician (OP)

  • If there is insufficient tissue or tumor content to run all of the clone(s) selected

  • If there is no FDA-approved test in that tumor type (scoring method only, test is still OP choice)

In the event it is necessary, our order of prioritization is outlined below.

Clone Prioritization

Tumor Type

Default PD-L1 IHC Clone and Scoring Method 2nd Choice PD-L1 IHC Clone and Scoring Method 3rd Choice PD-L1 IHC Clone and Scoring Method

Dako 22C3 TPS*

Ventana SP142 TC and IC*

Dako 28-8 Tumor Cell Expression (%)*

Default PD-L1 IHC Clone and scoring method 2nd Choice PD-L1 IHC Test and Scoring Method 3rd Choice PD-L1 IHC Test and Scoring Method

Dako 22C3 CPS*

Dako 28-8 CPS

Ventana SP142 TC and IC

Default PD-L1 IHC Test and scoring method 2nd choice PD-L1 IHC test and scoring method 3rd choice PD-L1 IHC test and scoring method

Dako 22C3 CPS*

Dako 28-8 Tumor Cell Expression (%)

Ventana SP142 TC and IC

Default PD-L1 IHC Test and scoring method 2nd choice PD-L1 IHC test and scoring method 3rd choice PD-L1 IHC test and scoring method

Dako 22C3 CPS*

Ventana SP142 TC and IC*

Dako 28-8 Tumor Cell Expression (%)

Default PD-L1 IHC Test and scoring method 2nd choice PD-L1 IHC test and scoring method 3rd choice PD-L1 IHC test and scoring method

Dako 22C3 CPS*

Dako 28-8 Tumor Cell Expression (%)

Ventana SP142 TC and IC

Default PD-L1 IHC Test and scoring method 2nd choice PD-L1 IHC test and scoring method 3rd choice PD-L1 IHC test and scoring method

Dako 22C3 CPS*

Ventana SP142 TC and IC

Dako 28-8 Tumor Cell Expression (%)

Default PD-L1 IHC Test and scoring method 2nd choice PD-L1 IHC test and scoring method 3rd choice PD-L1 IHC test and scoring method

Dako 22C3 TPS

Dako 28-8 Tumor Cell Expression (%)

Ventana SP142 TC and IC

Need More Details?

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Additional Notes

*This test is FDA-approved as a companion diagnostic in this cancer type

This test is not FDA-approved for this cancer type

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.