Cancer diagnosis depends on the assessment of patient biopsies to determine tumor type, grading, and stage of malignancy. Pathologists visually review specimens and count mitotic figures (MF) in a variety of cancer types to help gauge aggressiveness, guide treatment, and inform patient prognosis. Current technology for recording MF counts in surgical pathology is lacking in objectivity, and enumeration of MF by microscopy can be error prone. In particular, a lack of systematic means for recording contributes to recognized variability. Cell counting instruments have been employed in the field as an attempt to address these issues. However, these instruments were not designed to assess the mitotic activity index for tumor grading, and they do not record MF microscopy field-of-view by field-of-view, do not function to sum the counts, and do not export data for inclusion in a pathology report.
This discovery provides a software application for the electronic recording, summation, and transcription of clinical data obtained during surgical pathology examination of patient tissues. This invention will enable standardization across diagnostic centers which will permit harmonization of MF counting by electronic means. Through standardization enabled by the application, interobserver variance in MF counting can be reduced and transcription errors eliminated, enhancing the accuracy of mitotic index generation that will improve patient care.
The National Cancer Institute (NCI) Laboratory of Cancer Biology and Genetics is seeking parties interested in licensing and /or co-development research collaboration of this technology for commercialization in quantitative and digital pathology fields.