VENTANA HER2 Dual ISH DNA Probe Cocktail assay (CE IVD)

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 and gastric 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 tumour 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

There is growing evidence that HER2 is an important biomarker and key driver of tumorigenesis in gastric cancer, with studies showing amplification or overexpression in 7–34% of tumours.⁵

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.

Gastric cancer has the third highest mortality rate, with more than 750,000 deaths per year.³

Multiple guidelines, including NCCN and CAP/ASCO^6,7, 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 and gastric carcinoma tissue specimens with the VENTANA Silver ISH DNP Detection Kit and the VENTANA Red ISH DIG Detection Kit, on the fully-automated BenchMark IHC/ISH instruments.
 

The VENTANA HER2 Dual ISH DNA Probe Cocktail is indicated as an aid in the assessment of patients for whom trastuzumab is being considered.

• 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

• Signals visualized at lower magnification, allowing pathologist to easily scan the entire tissue section to identify invasive carcinoma and tumour 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