Public source
Reviewed 21 Jul 2026
Completeness Fair (33%)
uPath HER2 Dual ISH image analysis, Breast
RocheThe 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.
Supported by 2 papers
General Information
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Organ/Specimen source
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Disease targeted
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Staining
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Regulatory Information
Pathway:
In Vitro Diagnostic Directive (IVDD)
Class:
General IVD Devices
Not verified by Health AI Register
Scanner Brands Certified for Use (CE-IVD)
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Scanner Models Certified for Use (CE-IVD)
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Other certifications
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Evidence & Research
Peer-Reviewed Papers
Prognostic impact of HER2 biomarker levels in trastuzumab-treated early HER2-positive breast cancer
Breast Cancer Research · Feb 2024
Improved concordance of challenging human epidermal growth factor receptor 2 dual <i>in‐situ</i> hybridisation cases with the use of a digital image analysis algorithm in breast cancer
Histopathology · Jun 2023
Technical Specifications
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Market Presence
On market since
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Pricing Information
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Based on
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Source: Public | First published: Apr 22, 2026 | Last updated: Jul 21, 2026