Owkin rolls out its landmark AI diagnostic within Medipath, the largest network of pathologists in France

Owkin has successfully validated its MSIntuit™ CRC AI solution for colorectal cancer (CRC) screening, a major milestone in the use of AI to further improve precision diagnostics for the benefit of patients. The technology is now being integrated into clinical workflows via Medipath, France's largest network of pathologists.

Medipath will use Owkin’s diagnostic solution in its 34 pathology centers across France, helping to further enhance doctors’ diagnostic accuracy and the way patients are treated. Owkin's double-blind validation of the tool, which involved a cohort of 600 patients across two different scanners, delivered robust sensitivity rates of 0.98 and 0.96¹.

MSIntuit CRC is a CE-marked AI diagnostic that optimizes testing for microsatellite instability (MSI), a critical biomarker for CRC patients that represents a defect in a cell’s ability to correct mistakes that occur when DNA is replicated. Testing is now recommended by consensus guidelines, such as European Society for Medical Oncology (ESMO) in Europe and College of American Pathologists (CAP) in the US. MSI phenotyping is also essential to both the management of hereditary colorectal cancers and prognosis evaluation.

Colorectal cancer is the third most common cancer type worldwide, with almost 2 million cases diagnosed each year. It is one of the most preventable and treatable types of cancer, especially when detected early through regular screenings.

MSIntuit CRC is used for pre-screening and applies machine learning to digitized pathology slides to help pathologists and oncologists in their objective to facilitate better access to immunotherapy for all CRC patients.

Given the worldwide shortage of pathologists and the increasing number of biomarkers to be routinely screened in clinical practice, there is an ever-increasing need for solutions that ease biomarker testing in the clinic. MSIntuit CRC aims to have a significant impact on doctors and patients by decreasing workload and turnaround time, optimizing costs, and preserving tissue material and consumables. By using AI, this innovative tool supports reproducibility by addressing inter-observer variability, with the end goal of optimizing quality and efficiency for critical tests.

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Meriem Sefta, Chief Diagnostics Officer at Owkin, said:

Screening for MSI is a crucial step in diagnosing and treating colorectal cancer. We are delighted that MSIntuit CRC is now proven to be a highly-accurate tool for pathologists and oncologists and can now be used on patient cases. The deployment of it in pathology labs across France will make a lasting difference to the lives of thousands of patients.

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Dr. Nicolas Weinbreck, Vice President of Medipath, said:

The role of the pathologist is to establish the diagnosis of each patient's cancer as precisely as possible, and beyond that, to characterize all biomarkers, enabling truly personalized medicine. Today, determining MSI status is essential in the management of colorectal cancer, particularly with a view to potential immunotherapy. Owkin's MSIntuit CRC tool represents a quantum leap in the use of predictive AI, at the service of diagnosis and our patients. MSIntuit CRC enables us, as pathologists, to identify precisely and very quickly those patients who will require further molecular confirmation of their MSI status, and to preserve the best available tumor material.

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Owkin launched MSIntuit CRC for diagnostic use in the European Union in September last year.

_{¹ Svrcek M., Saillard C., Dubois R. 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}

_{MSIntuit CRC is CE-IVD marked for diagnostic use in the EU, and registered for use by the MHRA in the UK. In all other countries, including the United States, the use of the product is limited to research, not for use in diagnostic procedures. MSIntuit CRC is manufactured by Owkin France. It is intended for healthcare professionals for diagnostic use only where the products are authorized. For detailed information on proper use and precautions, please read carefully the instructions for use provided with the product.}

About Medipath

Founded in 1999, MEDIPATH gathers together over 120 independent pathologists (including 12 referent pathologists in the Institut National du Cancer's national expertise networks for rare pathologies, and 12 molecular pathologists) and more than 600 employees, spread geographically over 34 pathology centers. Managed by its partner-physicians, the company pursues a public health mission in cancer screening and diagnosis.

MEDIPATH works with over 250 healthcare establishments, processes over 1.5 million cases each year, and accounts for almost 10% of cancer diagnoses in France.

The excellence of its technical platforms, its active commitment to innovation and its geographical coverage enable MEDIPATH to successfully pursue its primary objective: "to offer its patients and corresponding healthcare professionals access to diagnostic excellence and the best local expertise".

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