IHC Testing

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Overview

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.

CLAUDIN18 IHC TESTING

We now offer IHC testing to evaluate Claudin18 (CLDN18) expression

VENTANA CLDN18 (43-14A) RxDx Assay
- Associated Therapy: Vyloy® (zolbetuximab)

Claudin18 IHC testing can identify patients with gastric and gastroesophageal junction cancer whose tumors are CLDN18.2-positive and may be eligible for treatment with Vyloy® (zolbetuximab)

Claudin18 IHC testing can be ordered through Foundation Medicine and requires 4-5 unstained slides (USS) + 1 H&E slide. See Claudin18 IHC One-pager for additional ordering details.

If you want to learn more, please Contact Us

Additional Claudin18 IHC Testing Documents

Claudin18 One Pager

HER2 IHC TESTING

We now offer IHC testing to evaluate HER2 expression

VENTANA 4B5 (PATHWAY anti-HER2 [4B5] antibody)

ENHERTU, a HER2-directed antibody and topoisomerase inhibitor conjugate, was recently approved for a new indication for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.^1,2 While not a CDx for this indication of Enhertu, the Ventana PATHWAY HER2 assay may help providers inform treatment decisions.

HER2 IHC can be ordered through Foundation Medicine. HER2 testing requires 4 additional unstained slides (USS) and 1 H+E slide. See HER2 IHC One-pager for additional ordering details.

Additional HER2 IHC Testing Documents

HER2 One Pager

FOLR1 IHC Testing

FOLR1 IHC TESTING

We now offer IHC testing to evaluate FOLR1 expression

VENTANA FOLR1 (FOLR1-2.1) RxDx Assay
- Associated Therapy: ELAHERE^TM (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 be ordered through Foundation Medicine. FOLR1 testing requires 4 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 four 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)
Ventana® PD-L1 SP263
- Associated therapies: Tecentriq^® (atezolizumab) and Libtayo^®
  (cemiplimab-rwlc)

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, SP142/Ventana SP142 or SP263/Ventana SP263). 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

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

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 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.

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)
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)

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.

PD-L1 Clone Prioritization

Select

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.

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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

^‡ 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.

Vyloy® is a registered trademark of Astellas Pharma, Inc. 

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.

Ventana Medical Systems, Inc.'s (Ventana) VENTANA CLDN18 (43-14A) Assay is a qualitative immunohistochemical assay using mouse monoclonal anti-claudin 18, clone 43-14A, intended for in vitro diagnostic (IVD) use for the assessment of claudin 18 (CLDN18) protein in formalin-fixed, paraffin-embedded (FFPE) gastric adenocarcinoma including gastroesophageal junction (GEJ) tissue specimens by light microscopy. This assay is used with OptiView DAB IHC Detection Kit for staining on a BenchMark ULTRA instrument. The assay is FDA-approved and is indicated as an aid in identifying patients with gastric or GEJ adenocarcinoma who may be eligible for treatment with VYLOY® (zolbetuximab) in accordance with the approved therapeutic product labeling. Test results of the VENTANA CLDN18 (43-14A) RxDx Assay should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls.

If you want to learn more, please Contact Us