MitProfiler Validation study

  • Research type

    Research Study

  • Full title

    Validation of the MitProfiler algorithm for the detection and quantification of mitotic figures in haematoxylin and eosin stained tissue sections.

  • IRAS ID

    342246

  • Contact name

    David Snead

  • Contact email

    d.snead@histofy.ai

  • Sponsor organisation

    Histofy Limited

  • Duration of Study in the UK

    0 years, 3 months, 31 days

  • Research summary

    MitProfiler is a computer algorithm which uses machine learning, a form of artificial intelligence, to train computers to recognise mitotic figures in pathology samples (that is samples of human or animal tissue prepared for microscopic examination). Mitotic figures are seen in cells which are dividing. They are the chromosomes in the cells which can be seen preparing to divide and separating into the daughter cells as the cells actually divide. They are an important feature of normal tissue biology (e.g. in growing regenerating tissue) and diseases such as cancer (where cells grow and divide in an uncontrolled manner). Pathologists see and count mitotic figures routinely in their work. Having the computer do this task saves time, reduces fatigue in pathologists and should deliver more consistent results as observations between individual human pathologists varies to some extent. Variration in By getting human pathologists and the MitProfiler algorithm to count mitoses in the same samples, this study aims to measure how closely the MitProfiler algorithm performs in comparison to human pathologists. If the results are as good or better than human pathologists the data derived will be used to support the regulatory approval of the device through the Medicines and Healthcare Regulatory Authority.

  • REC name

    London - Fulham Research Ethics Committee

  • REC reference

    25/LO/0158

  • Date of REC Opinion

    20 Feb 2025

  • REC opinion

    Favourable Opinion