MSIntuit® CRC

Optimize MSI testing for colorectal cancer

MSIntuit® CRC is a CE-marked AI diagnostic that provides a prescreen approach with digital pathology
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Clinical context

Facilitate better access to immunotherapy with microsatellite instability (MSI) testing

#2
In 2019 CRC was the second most common cause of death by cancer world-wide. 2
15%
MSI, a genomic biomarker, represents ~15% of overall CRC population; 3 playing an important role in determining treatment.
Prognostic
MSI patients show better prognoses and don’t benefit from chemotherapy in stage II. 4
Therapeutic
ICI has been approved for MSI patients, independent of the cancer type.
20%
Lynch Syndrome (HNPCC) represent 20% of MSI patients. 5
Testing
Current MSI screening techniques are MMR-IHC staining, MSI-PCR test, or Next-Generation Sequencing (NGS).

Immunotherapy has been approved for this subset of patients—prompting guidelines for universal screening. Furthermore, MSI status is reported to be predictive of response to immunotherapy across all solid tumors.

MSI tumors can also arise from a hereditary condition which increases the risk of developing cancers in multiple organs (Lynch syndrome). It is key to identify these patients and provide them with closer follow-up.

As demand for MSI screening for CRC patients (and beyond) increases, so too does the testing burden for pathologists and labs—creating bottlenecks and resource pressures.

MSIntuit CRC

Rule out patients with MSS phenotypes

Testing

Suitable for adults with primary colorectal cancer

Digital pathology

Works with surgically resected tissue on digitized H&E slides

95%
Sensitivity 1

Equivalent when compared to standard testing techniques

Workflow agnostic

Deployment is feasible across IMS systems or shared directory

PDF report

Delivered as a PDF report with user-friendly design

98%
NPV 1

Provides high confidence in MSS prediction by AI

MSIntuit Screen
Play
Video
Integrating MSIntuit® CRC into pathology workflow
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Impact

40% of CRC patients can be ruled-out from automatic IHC/PCR screening for MMR/MSI thanks to a sensitivity of 95% 1

MSS-AI patients can avoid additional testing thanks to a high diagnosis precision that enables a very low rate of false negative patients.

ESMO
Press release

Owkin’s MSIntuit CRC wins the Best Medical Technology Prix Galien Award

Owkin wins the Prix Galien Award in the category of Best Medical Technology for their product, MSIntuit® CRC.
Read the article

In clinical routine

A step towards increased lab capacity

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

Sample

Tissue sample is taken and prepared as H&E slide

Digitization

H&E slide digitized

AI solution diagram
AI solution

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

MSIntuit CRC

PDF report

Results

Results
‍
'Undetermined'

Patient recommended for a confirmatory MSI test

'MSS-AI'

Pathologist determines there is no need for additional testing

Confirmatory test

An IHC, PCR or NGS test is performed

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
Product CE marked
2022
Abstract presented at ESMO
2018
January
Jan
2020
August
Aug
2021
September
Sep
2022
May
May
2022
September
Sep

Citations

  1. Svrcek M, Saillard C, Dubois R, et al. Blind validation of MSIntuit, an AI-based pre-screening tool for MSI detection from colorectal cancer H&E slides. Poster presented at: European Society for Medical Oncology (ESMO);  May 9th - 13th 2022; Paris France.
  2. Mayur Amonkar et al. Journal of Clinical Oncology 2019
  3. https://gco.iarc.fr/today/data/ factsheets/cancers/10_8_9- Colorectum-fact-sheet.pdf
  4. Kawakami H et al. - Microsatellite instability testing and its role in the management of colorectal cancer. - Curr Treat Options Oncol. 2015
  5. Abu-Ghazaleh N et al. - Worldwide prevalence of Lynch syndrome in patients with colorectal cancer: Systematic review and meta-analysis. Genet Med. 2022
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 withmicrosatellite 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 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. Please contact Owkin to know where the product isregistered and commercialized.
*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 8th July 2024 - Version W001V2