VENTANA HER2 Dual ISH DNA Probe Cocktail - Acquired genetic alteration IVDs

Intended purpose

Intended to determine HER2 gene status by enumeration of the ratio of the HER2 gene to Chromosome 17 using two-color chromogenic in situ hybridization (ISH) in formalin-fixed, paraffin-embedded human breast and gastric carcinoma tissue specimens

Functional description

For determination of HER2 gene status by enumeration of the ratio of the HER2 gene to Chromosome 17 by light microscopy as an aid in identifying patients eligible for treatment with nominated therapies in selected indications.