VENTANA HER2 Dual ISH

You Spoke. We Listened.

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

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).

Product Specifications

Package Insert

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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

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

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

Breast carcinoma, 60X, Single copy HER2, nonamplified

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

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%.

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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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.

More coming soon!

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

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.