Breast cancer IHC/ISH portfolio

It’s why we do what we do.

Together with our partners, we’re committed to improving outcomes by providing the most comprehensive diagnostic tools that enable you to confidently deliver personalized results for every patient.

Our commitment to treating breast cancer includes over 25 assays, which can help accurately determine the tumor lineage and identify unsegmented patient populations that can help clinicians identify appropriate treatment options.

Why is this so important to us?

Because breast cancer is the most common cancer among women.

Every breast tissue sample received in the lab represents someone’s life. A life that deserves a swift, accurate diagnosis and treatment. Our tests focus on accurate results to help clinician care teams determine a patient’s personalized treatment path.

HER2-IHC

HER2 Dual ISH

Cornerstone Assays

Going further for breast cancer patients. Driving diagnostic certainty.

Breast cancer is a deeply personal experience that’s different for every patient. That’s why it’s so important to determine the type of breast cancer, and in turn, the right treatment path.

Since 1991, Roche Tissue Diagnostics has battled cancer with innovation. This comes in the form of the most comprehensive panel of advanced diagnostic tools that have the potential to profoundly change, and hopefully save, lives.

Clinical utility, superior specificity and sensitivity, and testing efficiency work together to create the big picture and ultimately our why—improved time to treatment for the patient.

Would you like to know more about our Breast cancer IHC/ISH portfolio?

Please submit your information in the following form to be contacted by a Roche representative with more details.

Let’s start with clinical utility.

The Roche Breast Cancer Diagnostics Portfolio solution provides you with all of the diagnostic assays and FDA-approved companion diagnostic biomarkers clinicians and patients need in the shortest possible time, quickly and reliably.

Superior specificity and sensitivity help you diagnose precisely and confidently.

Specific and sensitive rabbit monoclonal antibodies, best-in-class probes, and powerful detection systems help you diagnose precisely and confidently.

The benefits of testing efficiency reach far and wide.

Our comprehensive breast cancer portfolio delivers fully automated assays on market-leading platforms, with digital pathology and workflow solutions that reduce labor costs, free up resources, and improve time to results.

Pathology Lab product catalog

View our Pathology Lab product catalog to see our complete portfolio, including the many ways Roche supports customers.

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References

https://www.who.int/news-room/fact-sheets/detail/breast-cancer. Accessed 09/09/2024.
https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/breast-cancer-facts-and-figures/2024/breast-cancer-facts-and-figures-2024.pdf. Accessed 10/09/2024.

PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody Identifying HER2-low and HER2-ultralow expression

FDA-approved for patients with ALL levels of expression who may benefit from targeted treatment

Innovations in HER2-directed testing options deliver clear, confident results

First and only FDA-approved companion diagnostic for HER2/neu including HER2-low and HER2-ultralow expression

PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody is the only FDA-approved CDx for HER2-low and ultralow expression. It’s FDA approved as a companion diagnostic for the breakthrough designated therapy ENHERTU®* (fam-trastuzumab deruxtecan-nxki). It’s the first and only test to identify metastatic breast cancer (mBC) patients with low and ultralow expression of HER2 who may be eligible for targeted therapy.

*For more information on ENHURTU® please refer to the FDA-approved product labeling.

PATHWAY anti-HER2/neu (4B5) is a registered trademark of Roche Diagnostics.

Advancements in diagnostic testing give hope to your mBC patients with low and ultralow levels of HER2 expression

Previously, there were no HER2-directed treatment options for the more than 50 percent of patients with mBC who were considered HER2-negative.

Thanks to advances in drug development targeting lower ranges of HER2 expression and the diagnostic innovation of Roche, these patients may qualify for personalized treatment that could potentially lead to improved outcomes.

HER2-low and ultralow are clinically significant sub-groups of HER2 expression^1,2

100% of breast cancers tested for HER2

HER2-low FAQ—A Pathologist’s Perspective

Listen as Jim Richter, MD, Pathology Liaison within the Medical & Scientific Affairs division at Roche Diagnostics Corporation, provides insights on HER2-low from the pathologist’s perspective. He examines what HER2-low is, assessment/scoring, interpretation of tumor samples, related clinical trials, FDA approvals, patient care and safety, and so much more.

Discover how we’re going FURTHER.

To read our FAQs, please click here.

Indication for use: Breast cancer

View full table

Staining Pattern	HER2 Status	HER2 (4B5) Score (Report to treating physician)	Clinical Application
No membrane staining is observed*	HER2-null	IHC 0 absent membrane staining	NONE
Any staining of the membrane in greater than 0 and less than or equal to 10% of the cancer cells,,**	HER2-ultralow expression	IHC 0 with membrane staining	ENHERTU® (fam-trastuzumab deruxtecan-nxki)
Faint, partial staining of the membrane in greater than 10% of the cancer cells*	HER2-low expression	IHC 1+
Weak to moderate complete staining of the membrane in greater than 10% of the cancer cells	HER2-low expression	IHC 2+**** Reflex Test: HER2 non-amplified
	HER2 positive / overexpression	IHC 2+**** Reflex Test: HER2 amplified	HERCEPTIN® (trastuzumab), KADCYLA® (ado-trastuzumab emtansine) ENHERTU® (fam-trastuzumab deruxtecan-nxki) + PERJETA® (pertuzumab)
Intense complete staining of the membrane in greater than 10% of the cancer cells	HER2 positive / overexpression	IHC 3+

*Review at 40x is recommended to discern the presence or absence of any staining such as faint, partial staining
**Recommend re-reading by a second pathologist for cases with “faint, partial staining of the membrane” and %TC ≤ 5%
*** In the HER2-ultralow “IHC 0 with membrane staining” category, partial membranous staining is usually faint but may exhibit stronger intensities, and such rare cases are scored as HER2-ultralow if they do not otherwise qualify for a higher score. Examples are shown in the case image section. Challenging cases as well as unusual staining patterns are provided for reference.
****Recommend reflex test to assess gene amplification per ASCO/CAP guidance

A breakthrough in diagnostic testing is helping to improve outcomes for patients like Enisa, who are receiving new targeted treatment for HER2-low breast cancer.

Learn more about Enisa’s journey and how Roche helps women fight breast cancer.

Enisa's journey

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Confidently navigate the complexities of HER2 immunohistochemistry (IHC) testing in breast cancer

View this webinar to learn more about scoring and clinical significance of the newest companion diagnostic indication of PATHWAY anti-HER2 (4B5) for HER2-low.

Webinar

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Frequently Asked Questions

What is “HER2-low”?

HER2-low is a recently defined subtype of breast cancer categorized as “...faint, partial staining of the membrane in greater than 10% of the cancer cells” or “...weak to moderate complete staining of the membrane in greater than 10% of the cancer cells…” and has a HER2 /chromosome 17 ratio of less than 2.0 by a in situ hybridization assay.^2-4 In current guidelines, these categories are called 1+ or 2+, non-amplified.⁶ Although both 1+ and 2+ have historically been considered ineligible for HER2 targeted therapies, such as trastuzumab, data from the pivotal Phase III DESTINY-Breast04 clinical trial data demonstrates that patients with metastatic breast cancer classified as HER2-low derive substantial clinical benefit from fam-trastuzumab deruxtecan (ENHERTU^®) in the second line setting⁸ and enables a new treatment approach for patients that lacked treatment options.

What is the recommendation for patients who have already been tested for HER2?

Roche recommends that a freshly cut section of archived or recently collected sample of FFPE breast cancer be stained using the PATHWAY HER2 4B5 assay, using the locked staining procedure, U PATHWAY HER2 4B5 for the assessment of HER2-low.¹¹

All patients will have likely received previous diagnostic testing to determine their HER2 and HR status. These previous findings will be documented in the patient record and depending on institutional practices, stained glass slides may be archived. While the patient's historic record will provide a HER2 score and archived slides could be requested for review, but there are potential issues that may prevent accurate assessment of HER2-low with archived results and slides.

Can archived slides be utilized to determine HER2-low?

Can I use the original HER2 score to determine patient suitability for treatment with ENHERTU® (fam-trastuzumab deruxtecan-nxki)?

All patients will have likely received previous diagnostic testing to determine their HER2 and HR status. These previous findings will be documented in the patient record and depending on institutional practices, stained glass slides may be archived. While the patient's historic record will provide a HER2 score and archived slides could be requested for review, but there are potential issues that may prevent accurate assessment of HER2-low with archived results and slides.
Since the first publication of the practice guidelines for the diagnostic assessment of HER2 in breast cancer in 2007⁷, the guidelines have been updated twice in 2013 and 2018^1,6.
Several HER2 IHC assays have been used routinely since the first evidence of IHC testing for HER2 positive targeted therapy⁸. As such, historic HER2 scores may have been determined using a HER2 IHC assay other than the PATHWAY HER2 4B5 assay.
Staining protocols outside of the currently validated staining protocol for the PATHWAY HER2 4B5 assay may have been implemented at the time of diagnosis.
Although DAB is a stable relative to other chromogens used for IHC, fading does occur over time^9-10. Based on this potential limitation, archived glass slides stained with the PATHWAY HER2 4B5 assay may not have the same staining intensity as when they were initially reviewed.
The inability to accurately evaluate the role that these factors play in determining the initial diagnosis should be considered before using archived slides or the historic HER2 IHC score to determine HER2-low status.

Is the PATHWAY HER2 4B5 assay the only assay that can be used for evaluation of patient samples for treatment with ENHERTU® (fam- trastuzumab deruxtecan-nxki)?

The PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody was the only HER2 IHC assay used to select patients for the pivotal DESTINY-Breast04 clinical trial⁴ and is the only HER2 IHC assay approved by the FDA for determining patient eligibility for fam-trastuzumab deruxtecan-nxki treatment. Other HER2 IHC assays have not been validated in prospective clinical trials for fam-trastuzumab deruxtecan-nxki treatment.

While Roche has not evaluated the Pathway HER2 4B5 assay against other HER2 antibodies, data has shown that the Pathway HER2 4B5 antibody displays more sensitivity at the 1+ bin than another HER2 assay⁵.

What is the definition of “HER2-ultralow"?

In the PATHWAY anti HER2/neu (4B5) Rabbit Monoclonal Primary Antibody Interpretation Guide, HER2-ultralow is defined by IHC, as a breast cancer presenting any HER2 staining of the membrane in ≤10% of the tumor cells (“IHC 0 with membrane staining”).¹¹

What is the FDA-Approved assay for the identification of HER2-ultralow expression in breast cancer?

PATHWAY anti HER2/neu (4B5) Rabbit Monoclonal Primary Antibody is the first and only FDA-Approved assay for assessing HER2-ultralow expression.

What are the changes in the Method Sheet (package insert) and Interpretation Guide for the PATHWAY anti HER2/neu (4B5) Rabbit Monoclonal Primary Antibody assay for HER-ultralow?

Similar to other cut-offs and bins, for HER2-ultra low both intensity and completeness of cell membrane staining need to be evaluated. The updated Method Sheet and Interpretation Guide provide the following scoring criteria:¹³

View full table

HER2 (4B5) Score (Report to treating physician)	HER2 Status	Staining Pattern
IHC 0 absent membrane staining	HER2-null	No membrane staining is observed*
IHC 0 with membrane staining	HER2-ultralow expression	Any staining of the membrane in greater than 0 and less than or equal to 10% of the cancer cells,,**
IHC 1+	HER2-low expression	Faint, partial staining of the membrane in greater than 10% of the cancer cells*
IHC 2+**** Reflex Test: HER2 non-amplified	HER2-low expression	Weak to moderate complete staining of the membrane in greater than 10% of the cancer cells
IHC 2+**** Reflex Test: HER2 amplified	HER2 positive / overexpression
IHC 3+	HER2 positive / overexpression	Intense complete staining of the membrane in greater than 10% of the cancer cells

FAQ references

Wolff, A., Hammond, E., Allison, K., Harvey, B. et al. . Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer: American Society of Clinical Oncology/ College of American Pathologists Clinical Practice Guideline Focused Update. J Clin Onco 36, 2105-2122, doi:10.1200/JCO10.1200/JCO.2018 (2018).
Tarantino, P. et al. HER2-Low Breast Cancer: Pathological and Clinical Landscape. J Clin Oncol 38, 1951-1962, doi:10.1200/JCO.19.02488 (2020).
Zhang, H., Katerji, H., Turner, B. M. & Hicks, D. G. HER2-Low Breast Cancers. Am J Clin Pathol 157, 328-336, doi:10.1093/ajcp/aqab117 (2022).
Modi, S. et al. Trastuzumab Deruxtecan in Previously Treated HER2-Low Advanced Breast Cancer. N Engl J Med 387, 9-20, doi:10.1056/NEJMoa2203690 (2022).
Scott, M., Vandenberghe, M. E., Scorer, P., Boothman, A.-M. & Barker, C. Prevalence of HER2-low in breast cancer subtypes using the VENTANA anti-HER2/neu (4B5) assay. Journal of Clinical Oncology 39, 1021-1021, doi:10.1200/JCO.2021.39.15_suppl.1021 (2021).
Wolff, A. C. et al. Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Update. Journal of Clinical Oncology 31, 3997-4013, doi:10.1200/jco.2013.50.9984 (2013).
Wolff, A. C. et al. American Society of Clinical Oncology/College of American Pathologists Guideline Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer. Journal of Clinical Oncology 25, 118-145, doi:10.1200/jco.2006.09.2775 (2007).
Arnould, L. et al. Pathologic complete response to trastuzumab-based neoadjuvant therapy is related to the level of HER-2 amplification. Clin Cancer Res 13, 6404-6409, doi:10.1158/1078-0432.CCR-06-3022 (2007).
Ormerod, M. G. & Imrie, S. F. Enzyme-antienzyme method for immunohistochemistry. Methods Mol Biol 10, 117-124, doi:10.1385/0-89603-204-3:117 (1992).
Van Eycke, Y. R., Allard, J., Salmon, I., Debeir, O. & Decaestecker, C. Image processing in digital pathology: an opportunity to solve inter-batch variability of immunohistochemical staining. Sci Rep 7, 42964, doi:10.1038/srep42964 (2017).
PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody Method Sheet 14427US Rev K 2025-01-29.
https://www.fda.gov/news-events/press-announcements/fda-approves-first-targeted-therapy-her2-low-breast-cancer : Accessed October 2, 2022.
PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody Interpretation Guide for Breast Cancer 14991US Rev A.

Pathology Lab product catalog

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Reference

PATHWAY HER2/neu Rabbit Monoclonal Antibody Method Sheet 14427us Rev K 2025-01-29.

VENTANA HER2 Dual ISH DNA Probe Cocktail assay

Together, we can advance personalized healthcare with companion diagnostics

We do this by giving you diagnostic confidence from a broad menu of clinically relevant predictive assays. Our standardized, fully automated, and easy-to-use solutions enable rapid turnaround time, empowering physicians to make the right patient treatment decisions more quickly.

Going further for patients with breast cancer through innovation

Based on input from pathologists and lab professionals like you, Roche created the VENTANA HER2 Dual ISH Probe Cocktail assay as part of the Roche Tissue Diagnostics Breast Cancer IHC/ISH Portfolio.

FDA approved as an aid in the assessment of patients for whom HERCEPTIN®* (trastuzumab) or ENHERTU® (fam-trastuzumab deruxtecan-nxki) + PERJETA®** (pertuzumab) is being considered

Designed to improve turnaround time and first pass rates for confident results on the first read

Designed with brightfield technology for high-quality in-house testing

^{* For more information on HERCEPTIN® please refer to the FDA-approved product labeling.

** For more information on ENHERTU® + PERJETA® please refer to the FDA-approved product labeling.}

Optimized with oligo probes, the VENTANA HER2 Dual ISH assay delivers clear, confident results

The VENTANA HER2 Dual ISH Probe Cocktail is a fully automated, ready-to-use brightfield solution for determining HER2 gene amplification. VENTANA HER2 Dual ISH helps identify breast cancer patients eligible for treatment with HERCEPTIN® (trastuzumab).

Bringing HER2 breast cancer testing in-house can help deliver faster diagnoses and more personalized patient care

From its beginning in 1993, the Randy W. Cooper Center for Breast Health Services at Piedmont Healthcare Augusta has aimed to provide a rapid-turnaround screening process for breast cancer patients with the goal of speeding up the imaging and biopsy processing time to help get results for patients sooner.

Read the full story

A streamlined user experience

High-quality staining with best-in-class turnaround time and first pass rates, allowing pathologists to confidently deliver results on first read.

Innovative probe design
Anti-hapten detection kits
Enhanced target retrieval system

VENTANA HER2 Dual ISH demonstrated clinically meaningful first pass rates

The first pass rate for the VENTANA HER2 Dual ISH DNA Probe Cocktail assay on 40 breast samples fixed within the ASCO CAP guidelines (10% NBF for 6 to 72 hours) was 97.5% (87.1 – 99.6) on BenchMark ULTRA instruments. Specificity on the same 40 breast samples with negative control reagent was 100% (91.2 – 100) on BenchMark ULTRA instruments.¹

Robust and reproducible staining, giving clear, confident reads

Detection chemistry with anti-hapten technology results in unparalleled signal intensity without increased background.

Breast carcinoma, 60X, Single copy HER2, nonamplified

Breast carcinoma, 60X, HER2 clusters, amplified

Faster results with brightfield microscopy

The VENTANA HER2 Dual ISH assay is easily interpreted using brightfield microscopy,² which has proven concordance with fluorescence in situ hybridization (FISH),¹ enabling every lab the ability to run testing in-house that allows for faster results to the oncologist and their patient.

To evaluate the clinical sensitivity and specificity of the VENTANA HER2 Dual ISH DNA Probe Cocktail assay in determination of HER2 gene status in breast carcinoma, a multi-site method comparison study was performed using the Abbott/Vysis PathVysion HER-2 FISH Kit as the comparator device. Approximately 600 individual breast cancer cases were stained in 3 central laboratories.¹

Why brightfield is better:

No need for fluorescent microscope/oil and darkroom
Fits into pathologist’s regular workflow at brightfield scope
Can be read alongside/at same time as H&E and other breast panel markers on the same case for easy comparison and correlation of findings
No interference from tissue autofluorescence or tissue marking dyes
Produces archivable results
Signals do not fade over time

Aligned with multiple professional guidelines

VENTANA HER2 Dual ISH DNA Probe Cocktail assay is indicated as an aid in the assessment of patients for whom HERCEPTIN® (trastuzumab) or ENHERTU® (fam-trastuzumab deruxtecan-nxki) + PERJETA® (pertuzumab) is being considered.

Multiple guidelines, including NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)³ and American Society of Clinical Oncology/College of American Pathologists (ASCO-CAP),⁴ recommend the evaluation of human epidermal growth factor receptor 2 (HER2) protein expression in breast cancer.

General

What is the Product Intended Use for VENTANA HER2 Dual ISH?

The VENTANA HER2 Dual ISH DNA Probe Cocktail is intended to determine HER2 gene status by enumeration of the ratio of the HER2 gene to Chromosome 17 by light microscopy. The HER2 and Chromosome 17 probes are detected using the VENTANA Silver ISH DNP Detection Kit and the VENTANA Red ISH DIG Detection Kit by a two-color chromogenic in situ hybridization (ISH) in formalin-fixed, paraffin-embedded human breast carcinoma tissue specimens, following staining on the BenchMark ULTRA and BenchMark ULTRA Plus instruments. The VENTANA HER2 Dual ISH DNA Probe Cocktail is indicated as an aid in the assessment of patients for whom HERCEPTIN® (trastuzumab) or ENHERTU® (fam-trastuzumab deruxtecan-nxki) + PERJETA® (pertuzumab) is being considered. This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls. This product is intended for in vitro diagnostic (IVD) use.¹

What specifically has changed with the VENTANA HER2 Dual ISH DNA Probe Cocktail?

The new VENTANA HER2 Dual ISH DNA Probe Cocktail has a new probe design using oligonucleotide (or oligo for short) probes, which is a more specific, shorter probe. In addition, it is to be used in conjunction with two new detection kits with improved sensitivity (VENTANA Silver ISH DNP Detection Kit and VENTANA Red ISH DIG Detection Kit). Additionally, all three of these new materials are in a new kit size. The VENTANA HER2 Dual ISH DNA Probe Cocktail is now a 30 test kit and both VENTANA Silver ISH DNP Detection Kit and VENTANA Red ISH DIG Detection Kit are now a 60 test kit.

Does this new assay show improved performance and why?

The enhanced technology in the new assay shows improved performance in the following: New probe design allows for a shorter hybridization time which results in less failures and faster turnaround time. The hybridization step is shortened from approximately 6 hours to 1 hour, which decreases the chance for slide drying and associated speckling seen with previous generation HER2 SISH/Dual ISH assays. Also, the new detection kits, with hapten antibodies allow a more specific and sensitive reaction, resulting in brighter signal intensity making it easier and faster to read. Finally, the use of a part cell conditioning recovers more targets across a wider range of tissue pre-analytical conditions, and is largely responsible for the increase in first pass rates.

What is the classification of this product?

This product is an FDA Approved Class III PMA companion diagnostics product.

Has the current INFORM HER2 DUAL ISH assay been discontinued?

Yes, the INFORM HER2 DUAL ISH was discontinued January, 2022.

Has the current detection kits ultraView SISH DNP and ultraView Red ISH DIG been discontinued?

Only the ultraView Red ISH DIG Detection Kit was discontinued in January, 2022.

Running the assay

Can I run the new assay with the ultraView ISH Detection kits?

This assay is only validated with VENTANA Silver ISH DNP Detection Kit and VENTANA Red ISH DIG Detection Kit on BenchMark IHC/ISH instruments. Any deviation from the intended use stated in the package insert¹ is not recommended.

Are there recommended ISH best practices that should be followed?

Pre-analytical conditions can influence the result of any ISH assay. Studies have found that the majority of “inconclusive” HER2 gene results by fluorescent in situ hybridization (FISH) relate to pre-analytical factors including “under” and “over” fixation⁵ and delay to fixation.⁶ Strict implementation of fixation procedures (e.g., a dedicated processor to ensure a minimum of 6 hours fixation) resulted in a 64% reduction in “inconclusive” cases from 10.8% failures to 3.4%⁵. To compensate for those variable pre analytical factors, this assay has been developed with certain selectable protocol steps for pre-treatment. Refer to the package insert and Interpretation Guide² for the recommendations about pre analytical conditions as well as other recommendations such as glass slide storage and handling, label placement and others.

Will I need positive control slides for this assay?

Appropriately stained internal positive control nuclei are needed for interpreting results.²

Is there any special equipment required to run this assay?

No, the VENTANA HER2 Dual ISH DNA Probe Cocktail assay runs on the BenchMark ULTRA and BenchMark ULTRA Plus instruments and can be read on a standard brightfield microscope. No additional platforms, fluorescence microscope or special dark room handling required.

Can I coverslip on the VENTANA HE 600 system?

Roche Tissue Diagnostics performed an internal study that showed no difference in staining when the VENTANA HE 600 system is used compared to the Sakura Tissue-Tek coverslipper.

Can fixative types other than NBF be used with the new assay?

Only fixation in 10% neutral buffered formalin (NBF) is recommended as some fixatives produce variable staining with ISH-based assays, including Bouin’s and Alcohol Formalin-Acetic Acid (AFA).

Scoring and interpretation

Does scoring differ from the INFORM HER2 Dual ISH Assay?

The principle of slide scoring has not changed. Roche created an Interpretation Guide² for this assay, with the intention of providing readers with a tool to facilitate HER2 gene status determination via interpretation of HER2 and Chr17 staining patterns using the VENTANA HER2 Dual ISH DNA Probe Cocktail. In the Interpretation Guide, you can find recommendations on how to determine if a slide is adequate for slide scoring and explanations about the scoring algorithm to determine HER2 gene status.

Why is scoring different than CAP/ASCO?

All our studies are performed in accordance with the FDA approved scoring and the assay was compared to the FDA approved FISH assay.

Does this assay allow for the detection of polysomy?

Using a dual ISH test allows for the visualization of several staining patterns, including Chromosome 17 polysomy.²

Comparison with FISH

What are the benefits of HER2 Dual ISH compared to FISH?

No need for fluorescent microscope/oil immersion lens and darkroom
- Fits in pathologists’ regular workflow at brightfield scope.
- Her2 Dual ISH can be read alongside the H&E and other breast panel markers on the same case for easy comparison and correlation of findings.
- No interference from tissue auto fluorescence or tissue marking dyes.
Provides morphological context for the pathologist
- Signals visualized at lower magnification allowing a pathologist to easily scan the entire tissue section to identify invasive carcinoma and tumor heterogeneity.
- Counterstained with Hematoxylin II, like IHC slides, so morphologic features are preserved and visible.
- Allows distinction between invasive and in situ carcinoma, identification of normal cells and easy comparison to H&E slide and IHC slides.
- Normal cells provide a same slide internal control of the staining process so you can be confident in the results.
Archivable results
- Signals do not fade over time.
- Allows other pathologists to consult and review difficult cases.
- Slides can be stored long term alongside other H&E and IHC slides from the same case (no special storage needs).
- Clear and intense signals, along with Hematoxylin II counterstain, are easily imaged with conventional slide scanners

Is HER2 Dual ISH concordant to FISH?

Yes, included in the Package Insert is data showing that our test is highly concordant to FISH. The performance of these products is supported by significant data, including a clinical method comparison involving more than 600 breast cancer samples that analyzed the concordance of our assay with PathVysion FISH.¹

Educational Resources

Product Overview

Listen to a brief presentation from Roche pathologist Michael Lynch, MD, as he provides an overview of the new VENTANA HER2 Dual ISH assay.

Scoring the VENTANA HER2 Dual ISH Assay

In this short video, Roche pathologist, Michael Lynch, MD reviews the scoring method for the VENTANA HER2 Dual ISH assay as well as discusses scoring challenges and potential pitfalls.

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INFORM HER2 Dual ISH vs. VENTANA HER2 Dual ISH

This video walks through the design improvements to the new VENTANA HER2 Dual ISH assay and reviews comparison slides to its predecessor , INFORM HER2 Dual ISH assay.

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Understanding the Differences Between FISH and CISH Assays

Roche pathologist, Michael Lynch, M.D., discusses the differences between fluorescent in situ hybridization (FISH) and chromogenic in situ hybridization (CISH) and the practical implications to the laboratory.

Pathology Lab product catalog

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References

Ventana Product Document Library. Package Insert, VENTANA HER2 Dual ISH DNA Probe Cocktail.
Ventana Product Document Library. Interpretation Guide for VENTANA HER2 Dual ISH DNA Probe Cocktail assay; Staining for Breast Carcinoma.
Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Focused Update. Wolff AC, Hammond MEH, Allison KH, Harvey BE, Mangu PB, Bartlett JMS, Bilous M, Ellis IO, Fitzgibbons P, Hanna W, Jenkins RB, Press MF, Spears PA, Vance GH, Viale G, McShane LM, Dowsett M. J Clin Oncol. 2018 Jul 10;36(20):2105-2122.
NCCN Guideline for Invasive Breast Cancer, Version 5.2020. NCCN Clinical Practice Guidelines in Oncology Breast Cancer. NCCN.org.
Middleton LP, Price KM, Puig P, et al. Implementation of American Society of Clinical Oncology/College of American Pathologists HER2 Guideline Recommendations in a tertiary care facility increases HER2 immunohistochemistry and fluorescence in situ hybridisation concordance and decreases the number of inconclusive cases. Arch Pathol Lab Med. 2009;133(5):775-780.
Khoury T, Sait S, Hwang H, Chandrasekhar R, et al. Delay to formalin fixation effect on breast biomarkers. Mod Pathol. 2009;22(11):1457-1467.

Cornerstone Diagnostics Assays: Helping You Deliver Personalized Healthcare

Committed to helping you deliver personalized healthcare

Our mission is to improve the lives of all patients afflicted with cancer. By empowering pathologists with the highest quality, innovative tools and personalized diagnostics, we ensure timely and accurate diagnoses, and subsequently, better patient care.

Treatment isn’t one-size-fits-all. Bridging the gap between generic and personalized treatment, we’re steadfast in our commitment to accelerate the development of new assays with the power to improve and extend patients’ lives.

World-class antibodies to stratify breast cancer

CA-125 (OC125) Mouse Monoclonal Antibody

Ordering Number: 05267269001

Catalog Number: 760-2610

Quantity: 50 tests

Controls: Ovarian Carcinoma

Localization: Membranous, Cytoplasmic

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Breast cancer IHC/ISH portfolio

It’s why we do what we do.

Why is this so important to us?

HER2-IHC

HER2 Dual ISH

Cornerstone Assays

Going further for breast cancer patients. Driving diagnostic certainty.

Would you like to know more about our Breast cancer IHC/ISH portfolio?

Let’s start with clinical utility.

Superior specificity and sensitivity help you diagnose precisely and confidently.

The benefits of testing efficiency reach far and wide.

Pathology Lab product catalog

PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody Identifying HER2-low and HER2-ultralow expression

FDA-approved for patients with ALL levels of expression who may benefit from targeted treatment

Innovations in HER2-directed testing options deliver clear, confident results

First and only FDA-approved companion diagnostic for HER2/neu including HER2-low and HER2-ultralow expression

Advancements in diagnostic testing give hope to your mBC patients with low and ultralow levels of HER2 expression

HER2-low and ultralow are clinically significant sub-groups of HER2 expression1,2

HER2-low FAQ—A Pathologist’s Perspective

Indication for use: Breast cancer

Indication for use: Breast cancer

A breakthrough in diagnostic testing is helping to improve outcomes for patients like Enisa, who are receiving new targeted treatment for HER2-low breast cancer.

Confidently navigate the complexities of HER2 immunohistochemistry (IHC) testing in breast cancer

Frequently Asked Questions

Pathology Lab product catalog

VENTANA HER2 Dual ISH DNA Probe Cocktail assay

Together, we can advance personalized healthcare with companion diagnostics

Going further for patients with breast cancer through innovation

Optimized with oligo probes, the VENTANA HER2 Dual ISH assay delivers clear, confident results

Bringing HER2 breast cancer testing in-house can help deliver faster diagnoses and more personalized patient care

A streamlined user experience

VENTANA HER2 Dual ISH demonstrated clinically meaningful first pass rates

Robust and reproducible staining, giving clear, confident reads

Faster results with brightfield microscopy

Why brightfield is better:

Aligned with multiple professional guidelines

General

Running the assay

Scoring and interpretation

Comparison with FISH

Educational Resources

Product Overview

Scoring the VENTANA HER2 Dual ISH Assay

INFORM HER2 Dual ISH vs. VENTANA HER2 Dual ISH

Understanding the Differences Between FISH and CISH Assays

Pathology Lab product catalog

Cornerstone Diagnostics Assays: Helping You Deliver Personalized Healthcare

Committed to helping you deliver personalized healthcare

World-class antibodies to stratify breast cancer

CA-125 (OC125) Mouse Monoclonal Antibody

Calponin-1 (EP798Y) Rabbit Monoclonal Antibody

E-cadherin (36) Mouse Monoclonal Primary Antibody, VENTANA

E-cadherin (EP700Y) Antibody

Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody, CONFIRM

GATA3 (L50-823) Mouse Monoclonal Primary Antibody

GCDFP-15 (EP1582Y) Rabbit Monoclonal Antibody

GLIAL Fibrillary Acidic Protein (EP672Y) Rabbit Monoclonal Antibody

Growth Hormone (polyclonal)

Ki-67 (30-9) Rabbit Monoclonal Primary Antibody, CONFIRM

P53 (BP53-11) Primary Antibody

P53 (DO-7) Primary Antibody, CONFIRM

P57 (Kp10) Mouse Monoclonal Primary Antibody

P63 (4A4) Mouse Monoclonal Primary Antibody, VENTANA

P120 CATENIN (98) Mouse Monoclonal Primary Antibody, VENTANA

PAX8 (MRQ-50) Mouse Monoclonal Primary Antibody

PLAP (NB10)

Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody

PTEN (SP218) Rabbit Monoclonal Primary Antibody

Topoisomerase IIα (JS5B4) Rabbit Monoclonal Primary Antibody

Actin, Smooth Muscle (1A4) Mouse Monoclonal Antibody

Caldesmon (E89) Rabbit Monoclonal Primary Antibody

Cytokeratin (35betaH11) Mouse Monoclonal Primary Antibody

Pathology Lab product catalog

Predictive Diagnostic Pipeline

Investing in the future means investing in all of our futures

What’s in the pipeline?

Building a robust pipeline of predictive diagnostics

Want even more details about what we’re up to for the future and how it could be of benefit to you?

HER2-low and ultralow are clinically significant sub-groups of HER2 expression^1,2