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uPath HER2 Dual ISH image analysis, Breast (CE-IVD)

Ready-to-use, fast, consistent and automated algorithm for clinical decision support

Roche uPath HER2 Dual ISH image analysis (CE-IVD) for Breast

uPath image analysis algorithms

The Roche 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 Chromosome17, 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 treatment is being considered.

 

Roche uPath HER2 Dual ISH image analysis, Breast features
  • Pathologist-trained artifical intelligence algorithm: Resulting in objective and reproducible scoring of VENTANA DP 200 slide scanner slide images stained with the VENTANA HER2 Dual ISH DNA Probe Cocktail assay
  • Integrated into the Roche uPath enterprise software: Seamless viewing, aligning and syncing functionality, sharing capabilities, and reporting
  • 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 gene amplification
 
 
Roche uPath HER2 Dual ISH image analysis heatmap
  • Heatmap: Intended to guide pathologists to areas for scoring based on an increase of HER2 signals relative to Chr17 signals
Roche uPath HER2 ISH ROI (region of interest) panel with heatmap
  • Clear visual overlay: Highlighting the 20 representative cells in red
  • ROI panel: Allowing pathologists to select identified cells and see the corresponding number of HER2 and Chr17 signals

Integrated and ready-to-use


Validated on VENTANA HER2 Dual ISH DNA Probe Cocktail assay, for use within Roche uPath enterprise software.

Quick and automated


Pathologist-trained artificial intelligence algorithm for quick image analysis.

Accurate, consistent and confident


Actionable assessment of scanned slide images that are objective and reproducible, aiding in informing on potential treatment strategies.

Roche uPath enterprise software (IVD) works with VENTANA digital pathology slide scanners
Roche uPath enterprise software (CE-IVD)
VENTANA HER2 Dual ISH DNA Probe Cocktail Assay CDx icon
VENTANA HER2 Dual ISH DNA Probe Cocktail assay (CE IVD)
High-resolution digital pathology slide scans with the VENTANA DP 200 slide scanner
VENTANA DP 200 slide scanner
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Roche uPath HER2 (4B5) breast image analysis algorithm (CE-IVD) product image
uPath HER2 (4B5) image analysis, Breast (CE-IVD)
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VENTANA PD-L1 (SP263) Assay (CE IVD)