Mindpeak Breast Ki-67 HS 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 the detection and classification of IHC stained tumor cells within whole slide images and identification of one or several tumor regions according to the hotspot method. Tumor cells are classified as not-stained (tumor negative) or stained (tumor positive).

A corresponding proliferation score is provided as the proportion of the number of tumor positive cells divided by the sum of tumor positive and tumor negative cells.