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IHC Testing

We offer select types of immunohistochemistry (IHC) testing as supplemental tests to our portfolio of comprehensive genomic profiling (CGP) tests for clinical customers.

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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.

FOLR1 IHC Testing

FOLR1 IHC TESTING

We now offer IHC testing to evaluate FOLR1 expression

  • VENTANA FOLR1 (FOLR1-2.1) RxDx Assay

    • Associated Therapy: ELAHERETM (mirvetuximab soravtansine-gynx)

FOLR1 (folate receptor alpha) IHC testing can identify patients with ovarian cancer, fallopian tube cancer, and primary peritoneal cancer who are folate receptor alpha-positive and may be eligible for treatment with mirvetuximab soravtansine-gynx.

FOLR1 IHC can only be ordered through Foundation Medicine for the tumor types indicated and cannot be ordered together with PD-L1 IHC testing. FOLR1 testing requires 5 additional unstained slides (USS) and 1 H+E slide. See FOLR1 IHC One-pager for additional ordering details.

If you want to learn more, please Contact Us

Additional FOLR1 IHC Testing Support:

FOLR1 IHC One-pager

PD-L1 IHC Tests

We offer three IHC tests to evaluate PD-L1 expression:

  • Dako® PD-L1 IHC 22C3 pharmDx

    • Associated therapies: Keytruda® (pembrolizumab) and Libtayo® (cemiplimab-rwlc)

  • Dako® PD-L1 IHC 28-8 pharmDx

    • Associated therapies: Opdivo® (nivolumab) in combination with Yervoy® (ipilimumab)

  • Ventana® PD-L1 SP142

    • Associated therapy: Tecentriq® (atezolizumab)

When ordering PD-L1 IHC through Foundation Medicine, you are asked to select one (or more if appropriate) of these tests by choosing the associated clone (listed as 22C3/Dako 22C3, 28-8/Dako 28-8, or SP142/Ventana SP142). A patient’s tumor type and the therapies under consideration may inform your decision. Four additional slides are required per each clone selected (see the IHC Specimen Instructions for details). Please note that there may be billing implications if multiple clones are ordered.

PD-L1 IHC Testing Resources

IHC Specimen Instructions PD-L1 IHC One-pager

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. Non-small cell lung cancer has multiple options for approved clones, while other tumor types do not have any approved PD-L1 indications. In those cases, we will perform the test indicated on the order, or our Pathologists will use the Prioritization Table at the bottom of this page to select on your behalf.


You can use the tables below to help determine the most 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

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

Ventana SP142 TC and IC*

Dako 22C3 CPS†

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?

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

Contact Us

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

‡ This test is FDA-approved as a companion diagnostic in esophageal squamous cell carcinoma (ESCC)

1 Dako PD-L1 IHC 22C3 pharmDx. Package insert. Agilent Technologies, Inc. 2022. https://www.accessdata.fda.gov/cdrh_docs/pdf15/P150013S014C.pdf

2 Dako PD-L1 IHC 28-8 pharmDx. Package insert. Agilent Technologies, Inc.  2020. 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.

  • Ventana® FOLR1 (FOLR1-2.1) RxDx Assay. Package insert. Roche Diagnostics GmbH. 2022. https://www.accessdata.fda.gov/cdrh_docs/pdf22/P220006C.pdf

  • The VENTANA FOLR1 (FOLR1-2.1) RxDx Assay is for prescription use only and is a qualitative IHC assay intended for use in the assessment of folate receptor alpha (FOLR1) in formalin-fixed, paraffin-embedded epithelial ovarian, fallopian tube, or primary peritoneal cancer tissue specimens. This assay is FDA-approved and is indicated as an aid in identifying patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer who may be eligible for treatment with Elahere (mirvetuximab soravtansine-gynx). Test results should be interpreted in conjunction with relevant clinical information. For the complete label please visit https://www.accessdata.fda.gov/cdrh_docs/pdf22/P220006C.pdf

  • Ventana® is a registered trademark of Roche Diagnostics GmbH. ELAHERE™ is a trademark of ImmunoGen, Inc.