VENTANA HER2 Dual ISH DNA Probe Cocktail assay (US FDA Approved)

The new VENTANA HER2 Dual ISH DNA Probe Cocktail assay is a fully automated, ready-to-use brightfield solution for determining HER2 gene status. VENTANA HER2 Dual ISH helps identify breast cancer patients eligible for treatment with HER2-targeted personalized therapies.

Increased performance

• Oligo probes and new detection kits
• High first pass rates¹

Easily interpreted using brightfield microscopy²

• Allows for interpretation within the context of tissue morphology
• Identifies tumor heterogeneity
• Produces an archivable result

Robust & reproducible

• Highly concordant with FISH¹
• Highly reproducible between laboratories & pathologists¹

Diagnostic confidence

• Fully automated solution with fast turnaround time
• Widely adopted breast cancer portfolio with high clinical utility

Breast cancer comprises 24% of all female cancers and is estimated to claim the lives of more than 600,000 globally each year.³

15-20% of breast cancers overexpress HER2 and are eligible for HER2-targeted therapies, which are proven to improve outcomes.⁴

Demonstration of HER2 gene amplification and/or protein overexpression is essential for selecting patients for trastuzumab therapy.

Multiple guidelines, including NCCN and CAP/ASCO^5,6, recommend the evaluation of human epidermal growth factor receptor 2 (HER2) protein expression by immunohistochemistry (IHC) assay for breast cancer specimens. Depending on the IHC result, a reflex test should be performed-using in situ hybridization (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. This ready-to-use assay is optimized for use on formalin-fixed, paraffin-embedded human breast carcinoma tissue specimens with the VENTANA Silver ISH DNP Detection Kit and the VENTANA Red ISH DIG Detection Kit, on the fully-automated BenchMark ULTRA instruments.
 

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.

• Signals visualized at lower magnification, allowing 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 of the results
• Archivable results
• Signals do not fade over time

• No need for fluorescent microscope/oil and darkroom
• Fits in pathologists’ 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
• Avoids need for oil immersion lens

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 two-color chromogenic in situ hybridization (ISH) in formalin-fixed, paraffin-embedded human breast carcinoma tissue specimens, following staining on BenchMark ULTRA instruments.

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.

VENTANA Silver ISH DNP Detection Kit

The VENTANA Silver ISH DNP Detection Kit is an indirect system for detecting DNP-labeled targets. The kit is intended to identify targets by silver in situ hybridization (ISH) in sections of formalin-fixed, paraffin-embedded tissue that are stained on BenchMark IHC/ISH instruments.

This product should be interpreted by a qualified reader in conjunction with histological examination, relevant clinical information, and proper controls.

This product is intended for in vitro diagnostic (IVD) use.

VENTANA Red ISH DIG Detection Kit

The VENTANA Red ISH DIG Detection Kit is an indirect system for detecting DIG-labeled targets. The kit is intended to identify targets by chromogenic red in situ hybridization (ISH) in sections of formalin-fixed, paraffin-embedded tissue that are stained on BenchMark IHC/ISH instruments. 

This product should be interpreted by a qualified reader in conjunction with histological examination, relevant clinical information, and proper controls.

This product is intended for in vitro diagnostic (IVD) use.