Figure 2. VENTANA Silver ISH DNP Detection for HER2
Figure 3. VENTANA Red ISH DIG Detection for Chromosome 17.US-FDA
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
Easily interpreted using brightfield microscopy2
Robust & reproducible
Diagnostic confidence
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/ASCO5,6, 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.
References
