For in vitro diagnostic use. See country-specific product labeling for regulatory status. Digital Country Specific Labeling HER2 DUAL ISH IA ALGO BREAST IVD uPath HER2 Dual ISH image analysis, Breast PID00000382 09134433001 HER2 DISH algo breast IVD - 1.x uPath HER2 Dual ISH image analysis, Breast Electronic Services Not Available Not Available 09076239001 HER2 DISH algo breast RUO - 1.x uPath HER2 Dual ISH image analysis, Breast 07613336190388 Electronic Services Not Available Not Available RUO:The uPath HER2 Dual ISH image analysis, Breast algorithm is an adjunctive computer-assisted tool that enumerates HER2 gene signals and chromosome 17 signals within a pathologist-annotated viable tumor region in images of formalin-fixed, paraffin-embedded neoplastic breast tissue.For Research Use Only. Not for use in diagnostic procedures.IVD:The uPath HER2 Dual ISH image analysis for Breast algorithm is intended for use as an aid to the pathologist to determine HER2 gene status by enumeration of the ratio of the HER2 gene to Chromosome 17, in formalin-fixed, paraffin-embedded neoplastic breast tissue specimens. When used with the VENTANA HER2 Dual ISH Assay, it is indicated as an aid in the assessment of breast cancer patients for whom Herceptin ®(trastuzumab) treatment is being considered.Note: The uPath HER2 Dual ISH image analysis for Breast algorithm is an adjunctive computer-assisted methodology to aid in the acquisition and measurement of images from microscope glass slides of tissue specimens that have undergone color chromogenic in situ hybridization (ISH) to determine HER2 gene status. To assure the validity of Image Analysis scores, it is the responsibility of the pathologist to verify agreement by employing appropriate controls as specified in the VENTANA HER2 Dual ISH Assay method sheet (PN 1018383EN).This algorithm is intended for in vitro diagnostic (IVD) use. en