INFORM HER2 Dual ISH DNA Probe Cocktail Assay from Ventana Medical Systems, Inc.(Ventana) is intended to determine HER2 gene status by enumeration of the ratio of the HER2 gene to Chromosome 17. The HER2 and Chromosome 17 probes are detected using two color chromogenic in situ hybridization (ISH) in formalin-fixed, paraffin-embedded human breast cancer tissue specimens following staining on VENTANA BenchMark XT automated slide stainer (using NexES software) or on VENTANA BenchMark ULTRA automated slide stainer (using VSS software), by light microscopy. The INFORM HER2 Dual ISH DNA Probe Cocktail is indicated as an aid in the assessment of patients for whom Herceptin (trastuzumab) treatment is being considered.
This product should be interpreted by a qualified reader in conjunction with histological examination, relevant clinical information, and proper controls.
This reagent is intended for in vitro diagnostic (IVD) use.
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