Precision biomarker based on digital pathology and AI to guide personalized treatment decision support for colorectal cancer (CRC) patients

The digital biomarker Histotype Px® analyses routine H&E-stained whole slide images (WSI) of surgically resected cancer tissue, available for all patients globally. It is developed with end-to-end deep learning AI, allowing the neural networks to identify features of good and poor outcome. The training material consists of millions of image tiles sampled from thousands of patients from different labs, making it robust and generalizable. When combined with pathological staging parameters such as tumor and lymph node status, our lead product Histotype Px Colorectal can classify low- and high-risk patients with a HR=10.7 (95% CI 6.4-17.9, p<0.0001, Lancet Oncology, 2022). The application can easily be implemented in local pathology labs, and within minutes provide valuable information for treatment decisions. The focus areas for DoMore Dx going forward are related to market awareness, acceptance to end-users, product scale up as a cloud solution ready for API-based integration. This project will enable: 1) conducting large scale clinical validation with a number of relevant cohorts, which is essential to convince clinicians and get into clinical guidelines; 2) conducting clinical utility studies in key markets to convince public and private payors towards reimbursement; 3) mature the cloud platform for easy integration with partners and 4) handle regulatory affairs to achieve approval / clearance for commercialization in key markets, all the while 5) carrying out business development activities. The EIC Accelerator program provides a unique opportunity for DoMore Dx to showcase the potential of its technology and generate significant evidence that will ultimately lead to acceptance by end-users. The completion of the project objectives is important for ensuring a successful entrance to the market and commercialization of our innovative digital biomarker.