Mindpeak Breast HER2 RoI

CE | Breast | Amplifier Integrator | HER2

Description of use

Mindpeak Breast HER2 RoI is intended for in vitro diagnostic use as an aid to the pathologist in the assessment of samples from human breast cancer patients.

Image analysis consists of detection and classification of IHC stained tumor cells within predefined regions of interest (ROI). Tumor cells are classified according to membrane staining as not-stained, partially stained, complete but weakly stained, complete and strongly stained.

A HER2 score is provided based on the distribution of classified tumor cells within the regions of interest according to the latest clinical practice guideline of the American Society of Clinical Oncology and the College of American Pathologists (ASCO/CAP 2018): IHC 0, IHC 1+, IHC 2+ or IHC 3+.

The application content is provided by the respective AI vendors.