Cancer diagnosis is based on the assessment of patient biopsies to determine the tumor type, grade, and stage of malignancy. The proliferative potential of tumors correlates to their growth and metastasis. Visually identifying and quantifying mitotic figures (MF) in cancer biopsy tissue can be used as a surrogate for proliferative activity in tumors. The manual examination and quantification of stained tissue sections to determine tumor areas with the greatest number of MF, known as mitotic hotspots (HS), is subjective because the current method of assessment is based on the skill of the examining pathologist. In addition, the method used to determine HS is tedious, time-consuming, and error prone due to inter- and intra-observer variability. A newly developed technology addresses the issue of standardizing the assessment of tumor cell proliferation, yielding a diagnostic tool improves medical decision making and diagnostic precision.

This software tool identifies all tumor cell proliferating areas, maps foci in relation to the tumor tissue, and quantifies the proliferating cells for grading purposes. It provides MF metrics as a surrogate for tumor proliferative activity while also providing topographic information on HS locations. This new technology is a major improvement over current methods that use visual inspection and counting, which can result in the inclusion of erroneous findings during cancer grading. The software uses a computational approach by processing digital whole slide images (WSI) to render image grid tiles to extract immunolabeled MF and map the HS’s topographically to the tissue section of the WSI. This technology has demonstrated highly reproducibility unaffected by diagnostic skill level or work-fatigue. The automated approach represents a technology that requires minimal computational operations on image tile-based processing – while providing low complexity and enhancements in determining HS.

The National Cancer Institute (NCI) Laboratories of Pathology and Cancer Biology and Genetics are seeking parties interested in licensing and/or partnering in co-development research of this technology for commercialization in the field of clinical immunohistochemistry quantification.

Competitive Advantages:

• Computation approach to process whole slide images
• High reproducibility, unaffected by diagnostic skill level or fatigue
• Low complexity and enhancements in determining mitotic hotspots

Commercial Applications:

• Clinical immunohistochemistry quantification for improved cancer diagnosis
• Analytic software for improved cancer diagnosis