Liquid biopsy meets digital pathology: DoMore Diagnostics and leading Cancer Research center IFOM in Milan launch clinical validation study in early-stage colorectal cancer
OSLO – August 10, 2026 – DoMore Diagnostics, a leader in AI precision medicine for cancer, and AIRC Institute of Molecular Oncology today announce a collaboration to clinically validate the AI biomarker Histotype Px® Colorectal (Histotype Px). The collaboration brings together DoMore Diagnostics' expertise in deep learning-based digital pathology and IFOM's longstanding research activity in translational oncology, liquid biopsy and circulating tumour DNA (ctDNA). It reflects a shared commitment to generating high-quality clinical evidence that can directly inform treatment decisions for patients with localised colorectal cancer.
Colorectal cancer remains one of the most prevalent and lethal malignancies worldwide, yet treatment stratification for patients with localised disease has seen limited progress over the past two decades. A central challenge lies in identifying which patients with early-stage disease will benefit from adjuvant chemotherapy after surgery and which will not. Current clinical and pathological criteria leave a substantial proportion of patients either undertreated or exposed to the side effects of chemotherapy they do not need. Addressing this gap requires integrating complementary sources of biological information, combining tissue-based and blood-based approaches to build a more complete picture of tumour biology and individual prognosis.
The primary objective of the collaboration will be to evaluate the prognostic value of the Histotype Px biomarker when combined with ctDNA, and its potential additive prognostic value to circulating tumor DNA (ctDNA). This to follow up on the strong data in combination with ctDNA presented at ESMO in 2024 in 1082 stage II and III patients from the CIRCULATE-Japan GALAXY trial. In addition, the prognostic value of Histotype Px will be evaluated in a large retrospective cohort with stage I-III CRC. The clinical validation will include patients with stage II T4N0-III CRC from the PEGASUS trial (Nature Cancer, In Press) with post-surgery ctDNA, as well as a cohort of stage I-II low-risk patients from the AlfaOmega cohort, who were untreated after surgery.
The PEGASUS and AlfaOmega cohorts represent deeply annotated, prospectively collected datasets developed within IFOM's translational research programme. Their inclusion in this validation study reflects the value of long-term investment in clinical research infrastructure as a foundation for biomarker development.
“There is a pressing need to improve treatment stratification for patients with localized colorectal cancer and to better personalize adjuvant treatment decisions. Digital pathology and circulating tumor DNA may provide complementary biological and prognostic information, and it is therefore important to assess how these approaches perform both independently and in combination.
This collaboration will allow us to evaluate the prognostic value of Histotype Px in well-characterized early-stage colorectal cancer cohorts, including patients prospectively classified by postoperative liquid biopsy and ctDNA-based molecular residual disease assessment. Understanding where pathology-based AI and ctDNA converge, and where they capture distinct aspects of tumor biology, may ultimately prove more informative than considering either approach in isolation,” said Dr. Silvia Marsoni, Principal Investigator at IFOM.
Torbjørn Furuseth MD, CEO and Co-Founder of DoMore Diagnostics said: “We are honored to be collaborating with Dr. Marsoni and IFOM ETS, one of the leading cancer researchers and research institutes in Italy and globally. Access to high quality clinical trial data is essential to the validation of Histotype Px. With this collaboration we are getting access to a unique dataset to further expand the clinical documentation of Histotype Px and evaluate the complementarity with ctDNA. Some of these patients were not treated with ACT, and it will be interesting to see the prognostic performance of Histotype Px as a standalone biomarker in this population.”
About Istituto Fondazione di Oncologia Molecolare (IFOM ETS)
IFOM, the AIRC Institute of Molecular Oncology – is a leading non-profit cancer research institute founded in Milan in 1998 by AIRC, Italy’s leading cancer charity. Its mission is to understand the molecular mechanisms underlying cancer initiation, progression, treatment resistance, and metastatic dissemination, and to translate this knowledge into more precise approaches to cancer prevention, diagnosis, and treatment.
Since the launch of its scientific programme in 2000, more than 50 research groups have contributed to advancing different frontiers of molecular oncology. Today, IFOM brings together 28 research group leaders and an international, multidisciplinary community of scientists working across biology, medicine, bioinformatics, genomics, physics, engineering, mathematics, immunology, digital pathology, and precision oncology. This diversity of expertise supports an integrated approach to cancer research, from fundamental discovery to clinically oriented translational programmes.
IFOM combines advanced technological platforms, experimental models, computational approaches, and deeply annotated patient cohorts to investigate the biological determinants of tumour evolution and therapeutic response. Its researchers maintain strong links with leading universities, hospitals, research institutes, biomedical organisations, and biotechnology partners in Italy and internationally. Building strategic alliances with highly competitive research centres worldwide, while remaining closely connected to clinical and institutional partners, is central to IFOM’s identity and to its mission of accelerating the translation of scientific discoveries into patient benefit.
About DoMore Diagnostics
DoMore Diagnostics uses artificial intelligence to make personalized treatment decisions simple and accessible for all cancer patients. Its unique digital biomarkers predict patient outcomes from routine tumor tissue slides and can be seamlessly integrated into pathologists’ existing workflow. The lead product Histotype Px® Colorectal is a CE-IVDD marked outcome prediction marker for stage II and III colorectal adenocarcinoma that informs the decision of whether to provide adjuvant chemotherapy following surgical resection of the tumor.
About Colorectal Cancer and Histotype Px® Colorectal
Colorectal cancer is the third most common and second most deadly cancer but has seen little innovation in diagnostics and treatment in the last decades. While adjuvant chemotherapy (ACT) may be offered after primary surgery to prevent disease recurrence, overtreatment is prevalent. Up to 85% of patients treated for stage II and stage III disease do not actually benefit from ACT, but still suffer from its side effects.
Histotype Px® is an advanced deep learning algorithm that analyzes digital histology slides, separating patients into distinct Low, Intermediate and High-risk groups to guide ACT treatment decisions. Data previously published in The Lancet and The Lancet Oncology showed that the test can accurately predict survival outcomes in colorectal cancer patients. Histotype Px® Colorectal was developed to provide clinicians with valuable information to guide personalized treatment decisions and improve patient outcomes.
For more information, please visit:
www.domorediagnostics.com
LinkedIn
The Lancet publication
The Lancet Oncology publication
Contact:
Torbjørn Furuseth, MD
torbjorn.furuseth@domorediagnostics.com