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Mitotic Figures Electronic Counting Application for Surgical Pathology

Summary
National Cancer Institute (NCI) researchers have developed a novel software tool for uniform recording of Mitotic Figure (MF) counts via conventional and/or digital microscopy. With this technology, diagnostic centers can standardize electronic recording, summation, and transcription of clinical data during surgical pathology examination. NCI seeks licensing partners to further develop this application for use in diagnosis and detection of malignant cancers.
NIH Reference Number
E-097-2019
Product Type
Keywords
  • Mitotic Figures, MF, Cell Proliferation, Counting, Electronic, Pathology, Surgical, Microscopy, Matrix Laboratory, MATLAB, Simpson
Collaboration Opportunity
This invention is available for licensing and co-development.
Contact
Description of Technology

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.  

Potential Commercial Applications
  • Quantitative Pathology 
  • Digital Pathology
Competitive Advantages
  • Systematic recordings of observation
  • Objective counts
  • Standard protocol for recording mitotic counts
  • Graphical User Interface in MATLAB
Development Stage
Publications

Wei BR, et al. Agreement in Histological Assessment of Mitotic Activity Between Microscopy and Digital Whole Slide Images Informs Conversion for Clinical Diagnosis.  [PMID 31321298]

Patent Status
  • Research Material: NIH will not pursue patent prosecution for this technology
Therapeutic Area
Updated
Wednesday, June 17, 2020