The intended purpose of CanRisk is to produce risk estimates for developing breast, ovarian or prostate cancer and for carrying a relevant pathogenic gene variant using cancer family history, genetic and other risk factors.

The Chancellor, Masters, and Scholars of the University of Cambridge
The Old Schools, Trinity Ln, Cambridge CB2 1TN

5070003842902

v4.0.0; Date of release: (2026-01-05) - 6698 [develop-3accc3a5]commit 3accc3a5e218d59f3959cdb48f74aa89adda4b0c (HEAD -> develop) Author: tcarver Date: Mon Jan 5 12:07:33 2026 +0000 update release date

See instructions for use at User Guide

The CanRisk Tool must only be used by qualified healthcare professionals. This version of the tool has been optimised for use in the specialist genetics setting.

This software product has been developed taking into account requirements from:

• ISO 13485:2016
  Medical devices - Quality management systems - Requirements for regulatory purposes.
• ISO 14971:2019
  Medical Devices - Application of risk management to medical devices.
• IEC 62304:2006
  Medical device software — Software life cycle processes.

See electronic instructions for use for any warnings and contraindications.

Report any serious incident to the manufacturer and the competent authority.