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Introducing the VENTANA HER2 Dual ISH Probe Cocktail assay, part of the Roche Tissue Diagnostics Breast Cancer IHC/ISH Portfolio. Based on input from pathologists and lab professionals like you, Roche created an enhanced assay with brightfield technology for high quality in-house testing so your lab has the ability to deliver results on the first read. And that benefits everybody, from your lab team to the clinicians and patients who rely on you for results. Because the best ideas for improving assays are the ones that come from you.

Built for quality. Built for reliability. Built for you.

 

US FDA Approved VENTANA HER2 Dual ISH DNA Probe Cocktail assay

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

The new 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).

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Redesigned to improve user experience and increase efficiency

High quality staining with improved performance in turn-around time and first pass rates, allowing pathologists to confidently deliver results on first read.

  • New probe design
  • New anti-hapten detection kits
  • Enhanced target retrieval system
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First Pass Rate

VENTANA HER2 Dual ISH demonstrated improved first pass rates compared to INFORM HER2 Dual ISH

Figure 2: Results from an alpha site study across 5 laboratories globally evaluating the performance of the VENTANA HER2 Dual ISH assay compared to INFORM HER2 Dual ISH

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Robust and reproducible staining, giving clear confident reads

New detection chemistry with improved anti-hapten technology results in unparalleled signal intensity without increased background.

More information can be found in the Interpretation Guide for VENTANA HER2 Dual ISH DNA Probe Cocktail assay; staining for breast carcinoma.2

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Breast carcinoma, 60X, Single copy HER2, nonamplified

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Breast carcinoma, 60X, HER2 clusters, amplified

The VENTANA HER2 Dual ISH assay is easily interpreted using brightfield microscopy2 which has proven concordance with FISH1 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 three central laboratories.1

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Table 1: Summary of negative, positive, and overall agreement rates for VENTANA HER2 Dual ISH DNA Probe Cocktail and Abbott/Vysis PathVysion HER-2 DNA Probe Kit. The overall percent agreement between the VENTANA HER2 Dual ISH DNA Probe Cocktail and Abbott/Vysis PathVysion HER-2 DNA Probe Kit is 92.7%.

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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 auto fluorescence or tissue marking dyes
  • Produces archivable results
  • Signals do not fade over time

 

 

Indicated as an aid in the assessment of patients for whom HERCEPTIN (trastuzumab) in being considered

Multiple guidelines, including NCCN4 and CAP/ASCO3, recommend the evaluation of human epidermal growth factor receptor 2 (HER2) protein expression in breast cancer.

Figure 3: Example case for primary use of IHC to determine HER2 status
Source: Diagram based on NCCN Guideline for Invasive Breast Cancer Version 5, 2020

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Educational Resources

Product Overview

Listen to a brief presentation from Roche Pathologist, Michael Lynch, M.D., 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, M.D. reviews the scoring method for the VENTANA HER2 Dual ISH assay as well as discusses scoring challenges and potential pitfalls.

VENTANA HER2 Dual ISH Scoring Form

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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CAP/ASCO HER2 2018 Guideline Update and Roche HER2 Assays

Roche Pathologist, Dr. Bharathi Vennapusa, MD, reviews CAP/ASCO 2018 Guideline update for HER2 testing in breast cancer and how it pertains to Roche HER2 assays.

Podcast  

Frequently Asked Questions

General

General

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 instrument. The VENTANA HER2 Dual ISH DNA Probe Cocktail is indicated as an aid in the assessment of patients for whom Herceptin® (trastuzumab) 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

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.

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.

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

Yes, the current assay will be discontinued on 12/31/2021 or when supply is depleted, which may occur earlier.

Only the ultraView Red ISH DIG Detection Kit will be discontinued on 12/31/21 or when supply is depleted, which may occur earlier.

Running the Assay

Running the Assay

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.

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.

Appropriately stained internal positive control nuclei are needed for interpreting results.2 Roche recommends the use of HER2 Dual ISH 3-in-1 Xenograft Slides for initial assay installation and/or troubleshooting activities.

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

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.

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 & Interpretation

Scoring & Interpretation

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.

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

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

Comparison with FISH

Comparison with 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

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

The VENTANA HER2 Dual ISH Probe Cocktail is part of the comprehensive breast solution offered by Roche aimed at helping inform decision making in cancer care and contributing to improved patient outcomes

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  1. Ventana Product Document Library. Package Insert, VENTANA HER2 Dual ISH DNA Probe Cocktail.
  2. Ventana Product Document Library. Interpretation Guide for VENTANA HER2 Dual ISH DNA Probe Cocktail assay; Staining for Breast Carcinoma.
  3. 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.
  4. NCCN Guideline for Invasive Breast Cancer, Version 5.2020. NCCN Clinical Practice Guidelines in Oncology Breast Cancer. NCCN.org.
  5. 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.
  6. 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.