Peer-reviewed evidence for Colosafe® and stool SDC2 methylation testing in bowel cancer screening.
Preliminary findings from an ongoing prospective study at St Vincent's University Hospital, Dublin, evaluating Colosafe® across colonic tissue and stool samples against colonoscopy and pathology. Full results will follow peer review.
A progressive, stepwise increase in SDC2 methylation was observed across the neoplastic spectrum.
In 83 matched stool samples, SDC2 methylation analysis demonstrated a 98.3% negative predictive value for the exclusion of advanced colorectal neoplasia.
These preliminary findings support SDC2 methylation as a biologically grounded marker of colorectal neoplasia, and indicate that a negative Colosafe® result is associated with a low likelihood of advanced disease in this cohort.
Hanly, M. et al. (2026). Progressive SDC2 Hypermethylation Across the Colorectal Carcinogenesis Pathway in a European Population [Unpublished manuscript]. St Vincent's University Hospital, UCD School of Medicine. Figures will be amended following peer-reviewed publication.
Published in Gastroenterology, Clinical Epigenetics, the American Journal of Gastroenterology and other leading journals between 2017 and 2025, the studies summarised below establish the performance of stool SDC2 methylation testing on which Colosafe® is built.
The core scientific references establishing Colosafe® as a validated stool DNA methylation test for bowel cancer.
Tested Colosafe in 1,110 participants against colonoscopy as the reference standard. Detected 83.8% of bowel cancers — including 87% of stage I–II cases — while correctly clearing 98% of healthy participants.
The original validation of stool SDC2 methylation as a bowel cancer biomarker. Detected 81.1% of cancers with 93.3% specificity.
Large-scale studies showing how Colosafe® performs in routine screening, including direct comparisons with the faecal immunochemical test (FIT).
Prospective community screening across 49 sites in asymptomatic adults aged 45–75. Colosafe detected more advanced adenomas and bowel cancers than FIT alone; combining both tests improved yield further.
Retrospective real-world analysis of 113,209 adults tested with fecal SDC2 methylation over four years. 10.4% tested positive; of those who went on to colonoscopy, one in four (26.7%) were found to have bowel cancer or an advanced adenoma.
Ran SDC2 methylation and FIT on stool from the same 10,578 screening-naïve adults — the only large study to do so. Provides like-for-like performance data directly relevant to FIT-based programmes such as BowelScreen.
Compared Colosafe against faecal occult blood testing in 1,035 high-risk patients. Colosafe detected 87.5% of bowel cancers with 95.6% specificity, significantly outperforming FOBT in the same cohort (AUC 0.914).
Independent studies evaluating the underlying biomarker across multiple commercial tests and populations, establishing the credibility of the method on which Colosafe® is built.
US-authored meta-analysis pooling 46 studies and 16,149 patients. Concluded that SDC2 is the most accurate single-gene stool methylation marker available, with pooled 83.1% sensitivity and 91.2% specificity for bowel cancer.
Independent Italian review of the global commercial stool DNA methylation tests. Identifies Colosafe as one of five registered kits internationally, alongside Cologuard (USA) and EarlyTect-Colon (South Korea), citing 84.2% sensitivity and 97.9% specificity for bowel cancer.
For questions on the evidence base or to discuss integrating Colosafe® into your clinical practice, please contact us.
