Owkin, a French-American biotechnology company that applies artificial intelligence (AI) to drug discovery, development, and diagnostics, today announced that it has entered into a collaboration agreement with MSD, the tradename of Merck & Co Inc., Rahway NJ USA to develop and commercialize AI-powered digital pathology diagnostics for the EU market.
Clinical trials have shown that the MSI-H tumor phenotype has potential prognostic and therapeutic importance, especially with the increased application of immune checkpoint inhibitor (ICI) therapies.1,2,3,4 As such, MSI-H has become an important genomic biomarker with applications across several types of cancer. As a result, testing for MSI-H is now recommended by consensus guidelines internationally.5,6,7,8
Meriem Sefta, 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.
This collaboration seeks to develop a pre-screening procedure to improve testing rates for MSI-H in endometrial, gastric, small intestinal, and biliary cancers. In these cancer types, MSI-H prevalence is low and MSI-H screening is not routinely performed. The collaboration will initially be focused in the European Union.
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.
Owkin, which currently has the only MSI digital pathology diagnostic CE-marked in colorectal cancer, will extend the development of its MSI-H AI diagnostics into four new cancer types, leveraging multimodal patient data from multiple academic centers and hospitals.
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.
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.
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 may also support reproducibility through addressing inter-observer variability, with the end goal of optimizing quality and efficiency for critical tests.
1 KEYNOTE-177 (Pembrolizumab in Microsatellite-Instability–High Advanced Colorectal Cancer) https://www.nejm.org/doi/10.1056/NEJMoa2017699
2 CheckMate 142 (Nivolumab (NIVO) ± ipilimumab (IPI) in patients (pts) with microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC): Five-year follow-up from CheckMate 142) https://ascopubs.org/doi/abs/10.1200/JCO.2022.40.16_suppl.3510
3 KEYNOTE-158 ( Pembrolizumab in microsatellite instability high or mismatch repair deficient cancers: updated analysis from the phase II KEYNOTE-158 study) https://pubmed.ncbi.nlm.nih.gov/35680043/
4 Dostarlimab for Primary Advanced or Recurrent Endometrial Cancer https://pubmed.ncbi.nlm.nih.gov/36972026/
5 ESMO recommendation, Annals of Oncology 30: 1232–1243, 2019
6 NICE [Accessed June 2023]
7 Cancer Ind. Évaluation du statut MMR tumoral / synthèse. 2021; [Accessed June 2023]