Histotype Px® Colorectal and ctDNA are complementary – data in colon cancer patients to be presented at the 2025 ASCO Annual Meeting

OSLO – May 26, 2025 – DoMore Diagnostics, a leader in AI and deep-learning for precision medicine for cancer, is pleased to announce that an abstract with the first European clinical validation of Histotype Px® Colorectal (Histotype Px) in combination with post-surgery circulating tumor DNA (ctDNA) will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting on May 31, in Chicago, IL. The findings demonstrate the added value of combining ctDNA with Histotype Px and suggest that combining ctDNA with Histotype Px has the potential to further improve risk stratification of colon cancer patients post surgery and reduce false negatives.

The study, led by leading oncologists and cancer researchers from the University Medical Center Utrecht (UMCU) and the Institute for Cancer genetics and informatics (ICGI) at Oslo University Hospital, included163 colon cancer patients from the Prospective Dutch ColoRectal Cancer (PLCRC, substudy PROVENC3), treated with radical resection and adjuvant chemotherapy (ACT). While ctDNA testing – a method that detects cancer remnants in the blood – has shown promise in identifying patients not cured by surgery, however, some cases are missed, leading to false negatives. Further risk stratifying ctDNA-negative patients with Histotype Px may therefore be an important addition to ctDNA tests to reduce false negatives and improve ACT decision making in the clinic.

It was found that among patients with no detectable ctDNA after surgery, Histotype Px identified 35% as high-risk who had a three-year recurrence rate (RR) of 35%, compared to an observed RR of only 9% in ctDNA-negative patients classified as low/intermediate-risk by Histotype Px (HR 4.2 [2.0-9.1], p<0.001).

Similar results have previously been reported in a large Japanese patient cohort, presented at the 2024 European Society for Medical Oncology (ESMO) congress, and together they pave the way for future prospective studies aimed at combining biomarkers like ctDNA and Histotype Px to personalize colon cancer treatment and improve patient outcomes.

Principal Investigator Prof. Jeanine Roodhart, MD, PhD, Department of Oncology, UMCU said:
“The current standard of care for stage III colon cancer patients is resection followed by ACT, however many patients have a low risk of recurrence and do not benefit ACT treatment. Post-surgery ctDNA may help identify patients not cured by surgery who may benefit from ACT, although false negative results remain a concern. This pilot study suggests that Histotype Px can improve the accuracy of ctDNA tests and reduce false negatives, confirming the potential clinical utility of Histotype Px in this setting. Future studies will aim to validate these results in a larger patient cohort.”

Torbjørn Furuseth, MD, Co-Founder and CEO at DoMore Diagnostics, commented,
"These results extend previous findings in a Japanese patient cohort to the European setting and again demonstrate that Histotype Px is not only a reliable risk classification tool on a stand-alone basis, but also that it can add significant clinical value together with ctDNA. Importantly, close to 60% of patients were classified as low/intermediate-risk by both methods and may represent a group who could safely avoid chemotherapy. The combination could thus become a new paradigm of truly personalized ACT treatment decisions. Histotype Px is a digital biomarker with short turnaround time, which makes it particularly valuable to enable early clinical decision making."

Live poster session:

Gastrointestinal Cancer – Colorectal and Anal
May 31 2025, 9:00 AM-12:00 PM CDT
Location: Hall A - Posters and Exhibits, Abstract 3604, Poster Board 273 
Title: Complementary value of a digital pathology biomarker to post-surgery circulating tumor DNA in risk stratification of stage III colon cancer patients receiving adjuvant chemotherapy. 

Link to Published Abstract.
DOI: 10.1200/JCO.2025.43.16_suppl.3604

Poster presented:

DoMore Diagnostics has been awarded an EIC Accelerator grant enabling our continued efforts to personalize cancer care with AI-powered biomarkers. 

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. Adjuvant chemotherapy (ACT) may be provided after primary surgery to prevent the disease from recurring, however overtreatment is prevalent with up to 85% of patients with stage II and stage III not benefitting from ACT and only suffering side effects.

Histotype Px® is an advanced deep learning algorithm that analyzes digital histology slides, identifying patients who may or may not benefit from adjuvant chemotherapy. Data previously published in The Lancet and Lancet Oncology showed 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
DoMore Diagnostics
torbjorn.furuseth@domorediagnostics.com