The integration of artificial intelligence (AI) into the medical devices industry is revolutionizing diagnostic processes, and Owkin’s MSIntuit® CRC is at the forefront of this transformation. Recognized for its innovative approach to colorectal cancer (CRC) screening, MSIntuit® CRC has garnered Innovation and Product Launches awards for Owkin in the 2024 Medical Device Network Excellence Awards for its significant contributions to AI diagnostics.
The Medical Device Network Excellence Awards celebrate the industry’s greatest achievements and innovations. Powered by GlobalData’s business intelligence, the program recognizes the people and companies that are driving change.
Owkin won the awards for launching MSIntuit® CRC, which facilitates better access to immunotherapy with microsatellite instability (MSI) testing. Its reliable performance, alignment with pathologists’ expertise, and expansion to other cancers with biopharmaceutical company MSD showcase its innovative impact.
Addressing the colorectal cancer screening challenge
Colorectal cancer is the second leading cause of cancer-related deaths worldwide. Precision therapies for patients with the Microsatellite Instability (MSI) biomarker, which represents about 15% of the overall CRC population, have made universal screening for MSI status crucial. However, this has increased pathologists’ workloads and delayed therapeutic decisions.
Owkin’s MSIntuit® CRC offers a solution by using AI to assist pathologists’ workflow, addressing the growing demands on pathology services. Furthermore, MSI status is a key factor in determining treatment, as MSI patients show better prognoses and do not benefit from chemotherapy in stage II. Immunotherapy, which has been approved for MSI patients regardless of cancer type, has prompted guidelines for universal screening.
The innovative process behind MSIntuit® CRC
The development of MSIntuit® CRC involved training a deep-learning model on a vast dataset of whole slide images, showcasing Owkin’s commitment to cutting-edge science. The model’s consistent performance across different scanners matches the sensitivity of gold-standard diagnostic methods, such as mismatch repair (MMR)/immunohistochemistry (IHC) staining, MSI-PCR test, or Next-Generation Sequencing (NGS). The pre-screening tool allows pathologists to efficiently rule out a significant number of non-MSI patients, streamlining the testing process.
MSIntuit® CRC is suitable for adults with primary colorectal cancer and works with surgically resected tissue on digitized H&E slides.
Impact on clinical practice and healthcare economics
The introduction of MSIntuit® CRC into clinical routines has the potential to transform MSI diagnosis for CRC patients. By delivering results in a matter of hours and demonstrating high sensitivity (96-98%) and specificity (47-46%), MSIntuit® CRC can alleviate the MSI testing burden and accelerate oncologist decision-making. The tool’s excellent inter-scanner agreement (Cohen’s κ: 0.82) further ensures its reliability in various clinical settings. Owkin’s forthcoming medico-economic evaluation aims to confirm the cost-saving potential of MSIntuit® CRC in cancer management.
With a high negative predictive value (NPV) of 98%, the AI provides high confidence in microsatellite-stable (MSS) prediction, and 40% of CRC patients can be ruled out from automatic IHC/PCR screening for MMR/MSI, thanks to the tool’s sensitivity.
Expanding the horizon: Owkin’s partnership with MSD
Owkin’s collaboration with MSD to develop and commercialize MSIntuit® CRC for additional cancer types, such as endometrial, gastric, small intestinal, and biliary cancers, demonstrates the scalability of this innovative tool. By leveraging multimodal patient data from multiple academic centers and hospitals, Owkin is setting a new standard for personalized cancer treatment across a broader range of solid tumor types.
Additionally, MSI tumors can arise from Lynch syndrome, which represents 20% of MSI patients and increases the risk of developing cancers in multiple organs. Identifying these patients is crucial for providing them with closer follow-up.
Enhancing pathologist insight through AI interpretability
MSIntuit® CRC not only provides rapid diagnostic results, but also supports pathologists’ understanding of the underlying pathology. The AI’s interpretability feature allows pathologists to identify inflammation and mucus in slide sections associated with MSI, bridging the gap between AI results and traditional pathology observations. The tool is workflow agnostic, allowing for deployment across IMS systems or shared directories, and delivers results as a user-friendly PDF report.
Arnaud Fouillet, Product Manager, Owkin
“We are thrilled and honored to receive the 2024 Medical Device Network Excellence Awards for Innovation and Product Launches. Our product, MSIntuit® CRC, is a testament to the power of AI in transforming the way we approach healthcare. MSIntuit® CRC is the first and only CE-marked AI diagnostic for MSI testing for colorectal cancer from digital H&E slides. This recognition reinforces our relentless dedication to advancing healthcare through innovative AI and data-driven solutions. At Owkin, we believe in the power of collaboration and technology to transform patient outcomes, and this award motivates us to continue pushing the boundaries of what is possible in medical research and development.”
Company Profile
Owkin is the first end-to-end AI biotech company on a mission to understand complex biology and ensure every patient gets the right treatment. We identify precision therapeutics, de-risk and accelerate clinical trials and develop diagnostics using AI trained on world-class patient data through privacy-enhancing technologies. We merge wet lab experiments with advanced AI techniques to create a powerful feedback loop for accelerated discovery and innovation in oncology, cardiovascular, immunity and inflammation. Owkin also founded MOSAIC, the world’s largest spatial multi-omics atlas for cancer research across seven cancer indications.
Owkin has raised over $300 million through investments from leading biopharma companies, including Sanofi and BMS, and venture funds like Fidelity, GV and Bpifrance, among others.
What makes us different?
Owkin is differentiated by a focus on improving our fundamental understanding of disease mechanics through data, biology and AI. We aim to improve the way we treat and diagnose diseases by using the latest technologies to advance fundamental scientific knowledge. We also believe that the future of precision medicine is in technologies that are able to unlock insights from the vast amount of patient data in hospitals and research centers in a privacy-preserving and secure way. By developing a cutting-edge federated learning framework while simultaneously building the world’s biggest and best network of hospitals, KOLs and high-quality, multimodal datasets, we are focused on making long-term, transformative improvements to medical research and drug development.
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