What is INIFY® Prostate?

INIFY® Prostate is an AI-based and CE-marked decision support tool that suggests and outlines suspected cancer areas in digital H&E whole-slide images of prostate biopsy samples.

The product is CE-marked according to EU Invitro Diagnostic Device Directive 98/79/EEC.

Intended use EU CE-mark

  • ContextVision’s Decision Support Tool, INIFY Prostate, is a Computer Aided Detection (CADe) Software which analyses digital H&E whole slide images of prostate biopsy samples, then suggests and outlines areas that contain glandular tissue without basal cells as well as areas with intraductal cancer, i.e. “suspicious” areas, in each image.
  • Glands without basal cells is typical for pathological tissue containing the most common prostate cancer type, acinar prostatic carcinoma.
  • INIFY Prostate can sort a working list to organize cases, and slides within each case, with the largest outlined areas on top, and measures % and outlined area against tissue area.
  • The sorting function can be altered if the hospital has other preferences, e.g. date of examination.
  • INIFY Prostate is intended to present image-related information that is interpreted by trained medical professionals, primarily pathologists.
  • INIFY Prostate does not directly generate diagnosis. The pathologist takes the final decision on clinical status.

INIFY Prostate delivery pack

  • Installation package
– USB stick
– PDST software package
  • Installation instructions
  • Instructions for use
  • Acceptance test protocol 

MasterAnnotation™ – for accurate, reliable performance

The INIFY® algorithms are trained on data from our MasterAnnotation method – a unique and patented innovation developed by ContextVision.
MasterAnnotation is our standardized procedure for generating training data. Briefly, a high-resolution multiplex immunofluorescence overlay is used to generate a precise annotation – an augmented ground truth – for the development and optimization of the INIFY algorithms.
In 2019, the MasterAnnotation method was granted patent protection by the U.S. Patent and Trademark Office (USPTO) – ContextVision’s first patent in the digital pathology field; patent US 10,572,996