HER2 (4B5) breast cancer algorithm by navify® Digital Pathology

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.
HER2 (4B5), breast cancer algorithm by navify Digital Pathology, product image
uPath HER2 (4B5) image analysis, Breast hero image

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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 HER2 (4B5) breast cancer algorithm by navify Digital Pathology* is an adjunctive computer-assisted tool that identifies HER2 positive tumor cell membrane within a pathologist-annotated viable tumor region in images of formalin-fixed, paraffin-embedded neoplastic breast tissue.

Elevate performance, alleviate laboratory demands

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Integrated and ready-to-use1

Validated for use with the Roche HER2 (4B5) clone and navify Digital Pathology.

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Quick and automated1

Pathologist-trained image analysis algorithm quickly calculates HER2 score.

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Accurate, consistent and confident1

Actionable assessment of slide images that are objective and reproducible.1

Explore the benefits of the HER2 (4B5) breast cancer algorithm by navify Digital Pathology*

HER2 (4B5), breast carcinoma algorithm by navify Digital Pathology features:

  • Pathologist-trained deep learning algorithm: Objective and reproducible scoring of slides stained with PATHWAY HER2 (4B5) Assay scanned on a VENTANA® DP 200 or DP 600 slide scanner
  • Embedded experience: Seamlessly integrated with navify Digital Pathology
  • Whole slide analysis (WSA): Automated pre-computing of the slide image prior to pathologist assessment, providing fast results for user-defined regions of interest (ROI)
  • Quick automated scoring: Quickly calculates HER2 status across all bins, including 0, 1+, 2+, and 3+, across all levels of HER2 expression
  • Clear visual overlay: Highlighting the presence of 1+, 2+, 3+ staining patterns and positive tumor cells at any intensity

Specifications

   
Scanner VENTANA DP 200 and VENTANA DP 600 slide scanners
Software navify Digital Pathology
Algorithm HER2 (4B5) breast cancer algorithm by navify Digital Pathology*
Assay PATHWAY® anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody
Tissue Type Breast
Scoring HER2 Score (0-3+)
Regulatory status Research Use Only (RUO)
4B5
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 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. Data on file.

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