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AI specialist Owkin and MSD (the trade name of Merck & Co.) have partnered to develop and commercialize AI-powered digital pathology tests.

The two companies aim to create pre-screening procedures to improve testing rates and results for microsatellite instability (MSI) screening in endometrial, gastric, small intestinal, and biliary cancers. The collaboration will initially be focused in the European Union.

In these cancer types, prevalence of MSI is low and screening is not routinely performed. But there is growing evidence that MSI levels are useful to determine who should receive immunotherapy.

Owkin currently has the only microsatellite digital pathology diagnostic CE-marked in colorectal cancer. Owkin’s MSIntuit CRC applies machine learning to digitized pathology slides and helps pathologists and oncologists better evaluate images to determine which patients are likely to respond to immunotherapy.  As reported recently in Nature Communications, the MSIntuit test showed almost 99% sensitivity for detecting those patients most likely to respond to immunotherapy.

Scott K. Pruitt, associate vice president and head, Translational Oncology, MSD Research Laboratories, said, “The application of AI technologies holds tremendous potential in the screening of patients and the diagnosis of disease. We look forward to working with the Owkin team toward harnessing this opportunity to identify more patients with MSI-H cancers who may benefit from ICI therapy.” 

Clinical trials have shown that the MSI High tumor phenotype has potential prognostic and therapeutic importance, including in the application of immune checkpoint inhibitors. MSI-High testing is already recommended by consensus guidelines internationally for certain cancers.

Meriem Sefta, Owkin’s chief diagnostics officer, said, “This strategic alliance with MSD is focused on improving the way patients are diagnosed and receive treatment, advancing our shared mission of supporting healthcare providers in their adoption of innovative digital diagnostics. It is clear that there is a need for AI diagnostics that can both ease bottlenecks and resource pressures while also ramping up biomarker testing to match patients with optimal treatments.”

Owkin’s MSIntuit CRC is a CE-marked AI diagnostic that optimizes testing for MSI, a critical biomarker for CRC patients. 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.

According to Owkin, they aim for MSIntuit to have a significant impact on doctors and patients by decreasing workload and turnaround time, optimizing costs, and preserving tissue material and consumables. The tool may also support reproducibility through addressing inter-observer variability, with the end goal of optimizing quality and efficiency for critical tests.

In other recent news, Owkin announced a new partnership with Cerba Path, a network of diagnostic labs. The two companies will work together to integrate Owkin’s AI-driven diagnostics into Cerba Path’s routine digital workflows and further validate AI-based tools for precision medicine. 

These tests will include Owkin’s RlapsRisk BC, which is designed to help physicians assess the risk of relapse in early breast cancer patients. Cerba Path will also integrate MSIntuit CRC, Owkin’s CE-IVD into its processes, and will participate in the validation of an extended version of the test spanning surgical resections and biopsies.

Owkin has also just inked a deal with France’s L’hôpital Bicêtre to launch a pilot program testing RlapsRisk BC.

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