IHC Testing
We offer select types of immunohistochemistry (IHC) testing, which complement our portfolio of comprehensive genomic profiling (CGP) tests for clinical customers.
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.3
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.4
Ventana PD-L1 SP142 Assay 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.5
Ventana PD-L1 SP263 Assay is a qualitative immunohistochemical assay using rabbit monoclonal anti-PD-L1 clone SP263 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.6
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 FDA-approved therapies associated with specific PD-L1 clones, while some other tumor types have fewer or no 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 suggest test prioritization on your behalf.
You can use the tables below to help determine the most appropriate clone for your patient.
PD-L1 IHC Clones by Tumor Type available in the United States
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) |
Ventana SP263 | Tumor Cell (TC) Score | Tecentriq® (atezolizumab), Libtayo® (cemiplimab-rwlc) |
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 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) |
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.
PD-L1 Clone Prioritization
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 | 4TH CHOICE PD-L1 IHC TEST AND SCORING METHOD |
---|---|---|---|
Dako 22C3 TPS* | Dako 28-8 Tumor Cell Expression (%)* | Ventana SP263 TC* | 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 | 4TH CHOICE PD-L1 IHC TEST AND SCORING METHOD |
---|---|---|---|
Dako 22C3 CPS‡ | Dako 28-8 CPS† | Ventana SP263 TC† | 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 | 4TH CHOICE PD-L1 IHC TEST AND SCORING METHOD |
---|---|---|---|
Dako 22C3 CPS* | Dako 28-8 Tumor Cell Expression (%)† | Ventana SP263 TC† | 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 | 4TH CHOICE PD-L1 IHC TEST AND SCORING METHOD |
---|---|---|---|
Dako 22C3 CPS† | Dako 28-8 Tumor Cell Expression (%)† | Ventana SP263 TC† | 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 | 4TH CHOICE PD-L1 IHC TEST AND SCORING METHOD |
---|---|---|---|
Dako 22C3 CPS* | Dako 28-8 Tumor Cell Expression (%)† | Ventana SP263 TC† | 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 | 4TH CHOICE PD-L1 IHC TEST AND SCORING METHOD |
---|---|---|---|
Dako 22C3 CPS* | Dako 28-8 Tumor Cell Expression (%)† | Ventana SP263 TC† | 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 | 4TH CHOICE PD-L1 IHC TEST AND SCORING METHOD |
---|---|---|---|
Dako 22C3 TPS† | Dako 28-8 Tumor Cell Expression (%)† | Ventana SP263 TC† | Ventana SP142 TC and IC† |
Need More Details?
Our client services team is here to help, Monday through Friday 8AM – 8PM EST.
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) and HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.
1. National Cancer Institute. https://www.cancer.gov/news-events/cancer-currents-blog/2024/fda-enhertu-her2-positive-solid-tumors. Accessed May 17, 2024.
2. Enhertu HCP Information Page. https://www.enhertuhcp.com/en/ihc3-plus-metastatic-solid-tumors. Accessed May 23, 2024.
3. Dako PD-L1 IHC 22C3 pharmDx package insert. Agilent Technologies, Inc.
4. Dako PD-L1 IHC 28-8 pharmDx package insert. Agilent Technologies, Inc.
5. Ventana® PD-L1 SP142 package insert. Roche Diagnostics GmbH.
6. Ventana® PD-L1 SP263 package insert. Roche Diagnostics GmbH.
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.
ELAHERE™ is a trademark of ImmunoGen, Inc.
Enhertu® is a registered trademark of Daiichi Sankyo Company, Limited.
Ventana Medical Systems, Inc.'s (Ventana) PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (PATHWAY HER2 (4B5)) is a rabbit monoclonal antibody intended for in vitro diagnostic (IVD) use for the semi-quantitative detection of HER2 antigen in sections of formalin-fixed, paraffin-embedded normal and neoplastic tissue. This assay is FDA-approved and it is indicated as an aid in the assessment of breast cancer patients for whom Herceptin® (trastuzumab), Enhertu® (trastuzumab deruxtecan), or KADCYLA® (ado-trastuzumab emtansine) treatment is being considered. This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls.
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