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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.

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This algorithm is intended for in vitro diagnostic (IVD) use.", "Name": "Intended Use" } ] } } ] }

uPath HER2 Dual ISH image analysis, Breast*

Ready-to-use, fast, consistent, and automated algorithm

uPath HER2 Dual ISH image analysis, Breast
uPath whole slide image analysis algorithms

An intelligent and advanced digital pathology solution requires artificial intelligence-based image analysis tools that empower pathologists to confidently and objectively assess whole tissue slide images.

The uPath HER2 Dual ISH image analysis, Breast algorithm is an adjunctive computer-assisted tool that enumerates HER2 and Chromosome 17 signals to determine HER2 gene status within a pathologist-annotated viable tumor region in images of formalin-fixed, paraffin-embedded neoplastic breast tissue.

Reap the benefits of intelligent design

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Integrated and ready-to-use


Validated for use with the VENTANA HER2 Dual ISH assay and Roche uPath enterprise software.

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Quick and automated


Pathologist-trained image analysis  algorithm quickly calculates HER2/Chr17 ratio.

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Accurate, consistent and confident


Actionable assessment of scanned slide images that are objective and reproducible.

Digital pathology
Inside the algorithm: uPath HER2 Dual ISH image analysis, Breast
  • Enhanced accuracy with a Pathologist-trained image analysis algorithm which results in objective and reproducible scoring of slide images scanned on VENTANA DP 200 slide scanner and stained with the VENTANA HER2 Dual ISH DNA Probe Cocktail
  • Fully embedded into the Roche uPath enterprise software to enable seamless viewing, aligning, syncing, sharing, and reporting
  • Speed up time to results for user-defined regions of interest with whole slide analysis (WSA) and automated pre-computing of the slide image prior to pathologist assessment
  • Quickly calculate HER2/Chr17 ratio

A heatmap guides pathologists to areas suitable for scoring based on an increase of HER2 signals relative to Chr17 signals.

ROI Panel

A clear visual overlay highlights socrable cells and identifies representative cells used to calculate HER2/Chr17 in red.

The ROI panel allows pathologists to select identified cells and see the corresponding number of HER2 and Chr17 signals.

Digital pathology solution

Maximize the potential of your digital pathology laboratory

The Roche Digital Pathology solution comprises high-performance hardware, software and uPath whole slide image analysis algorithms, and works in integrated harmony with the full Roche diagnostic portfolio for an end-to-end experience that enhances pathology workflows. 

Registration Status

*CE-IVD marked. For Research Use Only in the US. Not for use in diagnostic procedures in the US.

Refer to the product-specific labeling for the regulatory status of the scanner and uPath. When Research Use Only products are used with IVD products, the integrated workflow will be for Research Use Only and cannot be used for diagnostic procedures.



Technical Documents

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