uPath HER2 Dual ISH image analysis, Breast

Ready-to-use, fast, consistent, and automated algorithm
RUO For Research Use Only. Not for use in diagnostic procedures.
Country Specific Labeling See country-specific product labeling for regulatory status.
uPath HER2 Dual ISH image analysis, Breast
uPath HER2 Dual ISH image analysis, Breast

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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/ navify Digital Pathology.

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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.1

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 or VENTANA DP 600 slide scanner and stained with the VENTANA HER2 Dual ISH DNA Probe Cocktail1
  • Fully embedded into the Roche uPath enterprise software/ navify Digital Pathology 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
Heatmap

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 scorable 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.

Specifications

   
Scanner VENTANA DP 200 and VENTANA DP 600 slide scanners
Software Roche uPath enterprise software/navify Digital Pathology
Algorithm uPath HER2 Dual ISH image analysis, Breast*
Assay VENTANA HER2 Dual ISH DNA Probe Cocktail
Tissue Type Breast
Scoring HER2/Chromosome 17 Ratio
Regulatory status Research Use Only (RUO)
Dual-ISH
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. 

*For research use only. Not for use in diagnostic procedures. Roche is dedicated to clinically deploying its Digital Pathology Solutions and is actively pursuing approval/clearance for our portfolio of products. 

Roche Digital Pathology Dx, including navify Digital Pathology, is intended for specific clinical applications and is for research and educational use for other applications. Please review the product labeling for compliance before utilization. 

NAVIFY and VENTANA and UPATH are trademarks of Roche. Other product names and trademarks are the property of their respective owners.

 

Reference

1. Yoder A, Inge et al. Computer-aided scoring of erb-b2 receptor tyrosine kinase 2 (HER2) gene amplification status in breast cancer. J Pathol Inform. 2022 Jul 5;13:100116. doi: 10.1016/j.jpi.2022.100116. PMID: 36268099; PMCID: PMC9577051. https://pmc.ncbi.nlm.nih.gov/articles/PMC9577051/.

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