MSIntuit® CRC

Optimize MSI testing for colorectal cancer

Rule-out MSS cases from the diagnostic workflow by screening with digital pathology AI

Clinical context

Leap-frog molecular testing

#2
In 2023 CRC was the second most common cause of death by cancer world-wide.1
11%
MSI, a genomic biomarker, represents ~11% of overall CRC population;2 playing an important role in determining treatment.
ICI
MSI status is reported to be predictive of response to immunotherapy across all solid tumors.3

Benefits

Optimize laboratory resources

AI diagnostics help laboratories manage increasing testing demands by:
  • Reducing the need for confirmatory tests
  • Preserving valuable tissue samples for other diagnostic needs
  • Supporting pathologists with increasing workloads

MSIntuit CRC

Rule out patients with MSS phenotypes

Colorectal
Indication

Suitable for adults with primary colorectal adenocarcinoma.

70%
Streamlined case management

Offers up to 70% rule out.6

99%
NPV

Provides high confidence in MSS prediction by AI.6

Workflow agnostic

Deployment is feasible across IMS systems or shared directory.

MSIntuit Screen

Impact

Workload associated with MMR/MSI testing in clinical routine could be decreased by 50% for biopsies and 70% for surgical resections6

This enable centers to streamline their workflow, liberate auto-stainers and time for tasks with more added value and compensate for pathologist and technician shortage.

In clinical routine

A step towards increased lab capacity

Due to variability across pathology labs, workflows may vary by institutions and disease indications.

Sample tile
Digitization tile
AI solution tile
Results tile
Sample

The tissue sample is taken and prepared as H&E or HES slide.

Digitization

The slide is scanned and digitized.

AI solution

MSIntuit CRC deep neural networks extract and analyze features from the digitized slide.

RESULTS
MSS-AI

Patients can avoid additional testing thanks to high diagnosis precision.

Undetermined

Patients require further investigation to define microsatellite status with standard techniques.

Research and development

Timeline of milestones

2018
First proof of concept trained
2020
Peer reviewed research in Nature Communications publication.
2021
MICCAI science presented at COMPAY workshop
2022
The first version of MSIntuit CRC achieved CE-mark
2022
Abstract presented at ESMO
2023
'Validation of MSIntuit as an AI-based pre-screening tool for MSI detection from colorectal cancer histology slides' published in Nature Communications
2024
Poster presented at ECP
2025
Abstract accepted as a poster at USCAP
2018
Jan
Jan
2020
Aug
Aug
2021
Sep
Sep
2022
May
May
2022
Sep
Sep
2023
Nov
Nov
2024
Sep
Sep
2025
Mar
Mar

Citations

  1. World Health Organization. Colorectal cancer - WHO fact sheet, 2024
  2. Kang, YJ., O’Haire, S., Franchini, F. et al. A scoping review and meta-analysis on the prevalence of pan-tumour biomarkers (dMMR, MSI, high TMB) in different solid tumours. Sci Rep 12, 20495 (2022)
  3. Kawakami H, Zaanan A, Sinicrope FA. Microsatellite instability testing and its role in the management of colorectal cancer. Curr Treat Options Oncol (2015)
  4. Matias-Guiu, X., Temprana-Salvador, J., Garcia Lopez, P. et al. Implementing digital pathology: qualitative and financial insights from eight leading European laboratories. Virchows Arch (2025).
  5. Une nouvelle ère de l'Anatomie et de la Cytologie Pathologiques avec l'intelligence artificielle
  6. Results pending publication from MSIntuit CRC v2 performance validation at USCAP. A rule-out of 50% was obtained on biopsy samples, and 70% on surgical resection samples, 96% sensitivity on surgical resections, 95% sensitivity on biopsies, and 99% NPV for both surgical resections and biopsies, with 10% MSI prevalence.

MSIntuit CRC v1

MSIntuit® CRC is a medical device for use by healthcare professionals only. This deep learning software is intended to assist pathologists in the pre-selection of patients with microsatellite phenotype (MSS) / proficient mismatch repair system (pMMR) in colorectal tumors. It identifies MSS patients from a digitized histology slide image of hematoxylin and eosin (H&E) stained colorectal tissue resection for patients with primary colorectal cancer.
MSIntuit® CRC is intended to be used as an additional source of information for the pathologist when assessing MSS status and its results should not be used as the primary diagnosis. Pathologists should only use MSIntuit CRC in conjunction with their usual diagnostic criteria.
MSIntuit® CRC v1 is CE-IVD marked for diagnostic use. The device is not FDA-cleared nor approved in the United States, for use only in countries with applicable health authority registrations.

MSIntuit CRC v2

MSIntuit® CRC is a Class C (IVDR) medical device. The device is currently under development, and not for clinical use. The device is not FDA-cleared nor approved in the United States, for use only in countries with applicable health authority registrations.
Please contact Owkin for more information. Images shown may represent the range of products, or be for illustration purposes only, and may not be an exact representation of the product.
For detailed information on proper use and precautions, please read carefully the instructions for use provided with the product.
Manufacturer: Owkin France. MSIntuit® CRC is a trademark of Owkin Inc.
Information updated on 18th March 2025 - Version W001V2