TEST:

VENTANA HER2 Dual ISH DNA Probe Cocktail

The VENTANA HER2 Dual ISH DNA Probe Cocktail is intended to determine HER2 gene amplification 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 a 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. It is an enhanced version of the previous-generation test. This assay was launched as a CE IVD in April 2019.