Advancing Bowel Cancer Screening With Colosafe®

Information for Healthcare Professionals

FIT-based national screening programmes like BowelScreen have successfully improved early bowel cancer detection. However, next generation technology can provide additional benefits.

Limited colonoscopy capacity

Long waitlists create pressure on resources, with many referrals not having bowel cancer or high-risk polyps¹

Patient compliance

About 20% of FIT-positive patients in Ireland decline colonoscopy, indicating a need for more information²

Screening coverage gaps

Many at-risk individuals (age 45+) remain unscreened, missing the window for early detection

Innovative approaches are needed to expand screening reach and triage FIT-positive patients to reduce backlogs.

The Solution: DNA triage

Stool-based DNA testing, like Colosafe®, offers a non-invasive method to prioritise patients, helping fast-track those who need colonoscopy most.

What is Colosafe®?

Colosafe® is a home-based, non-invasive bowel cancer screening test that requires no fasting or bowel prep

What it is

DNA‑based stool test with an at‑home collection kit.

How it works

Detects methylated SDC2, a biomarker elevated in colorectal cancer (CRC).

Evidence & Use

Improved sensitivity vs FIT; +32.6% CRC detection without more false positives³.
Used by over 1 million patients globally.
Evaluated in an Irish population.

Key Clinical Benefits

Clinical Efficacy

84%

Sensitivity for CRC

98%

Specificity

Patient Adherence

Non-invasive and home-based with no dietary restrictions, leading to higher patient compliance.

Programme Integration

Complements existing FIT programmes and helps triage FIT-positive patients by analyzing molecular changes to improve overall screening accuracy.

Human SDC2 methylation detection

Colosafe® Testing Principle

Annotated colon section illustrating collection points for Colosafe testing

Stool DNA testing detects abnormal changes in exfoliated tumour cells (human SDC2 gene methylation) to help identify early bowel cancer lesions.

ExfoliationEpithelial & tumour cells shed into the lumen
CollectionExcreted with stool and collected for testing
ExtractionHuman DNA isolated from the stool sample
EnrichmentCapture of methylated DNA (patented technology)
AnalysisMethylation‑specific real‑time PCR for early CRC detection

Clinical Performance

The performance of Colosafe® has been well established in international studies and the Colosafe® test has already been used in routine clinical practice with over 1 million patients.

In a multi-centre clinical trial, Colosafe® demonstrated a sensitivity of 83.8% in all stages of bowel cancer, and 87% in Stage I-II CRC with an exceptional specificity of 98% in 1100 participants⁴.
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Sensitivity

83.8%

Specificity

98%

Sensitivity for advanced adenoma

42.1%

Sensitivity for stages I–II

87%

Adding clinical value when combined with FIT

Colosafe® complements FIT screening by addressing key gaps. Recent data (10,000+ patients aged 45-75, August 2024) demonstrates improved detection of serrated polyps and 99.86% negative predictive value (NPV), reducing both false negatives and colonoscopy burden without compromising specificity⁵.

Enhanced Sensitivity Profile

Colosafe® demonstrates strong detection capabilities with 86.2% sensitivity for colonoscopy-confirmed CRC compared to 65.5% for FIT (100 ng/ml cut-off), providing clinicians with an additional screening tool for patients who may benefit from heightened sensitivity⁶.

Colosafe® sensitivity (colonoscopy-confirmed CRC)

FIT sensitivity (colonoscopy-confirmed CRC)

Colosafe in the screening pathway

Adds molecular insight to your decision

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Who benefits from Colosafe?

FIT-Positive Individuals (Asymptomatic)

Helps confirm or prioritize the need for colonoscopy
Supports shared decision-making with patients

Symptomatic Individuals

Serves as a diagnostic aid alongside FIT
Adds molecular insight to improve detection

Colonoscopy Hesitant Individuals

Supplemental test for those hesitant about colonoscopy; supports informed discussion.

First line screen test for individuals not eligible for national screening programme

Accurate home-based test for average-risk individuals not eligible for the BowelScreen programme

Performance backed by clinical and scientific evidence

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Wang J et al. Robust performance of methylated SDC2 stool DNA test: multicenter clinical study. Clin Epigenetics. 2020;12:162. doi
Zhao S et al. Real-world stool-based SDC2 test improved detection of advanced neoplasia. Gastroenterology. 2024;167(3):611-614.e7. PubMed
Niu F et al. Stool DNA test of methylated SDC2 for early detection of colorectal neoplasia. Cancer Epidemiol Biomarkers Prev. 2017;26(9):1411-1419. PubMed
Wang L et al. Meta-analysis: diagnostic accuracy of SDC2 methylation testing. BMC Gastroenterol. 2022;22(1):314. Open access
Luo WF et al. Effectiveness of fecal SDC2 methylation testing in high-risk population. World J Gastrointest Oncol. 2024;16(4):1361-1373. Full text

▶ Show 6 more supporting studies

Oh T et al. SDC2 biomarker discovery (blood-based). J Mol Diagn. 2013;15(4):498-507. PubMed
Oh TJ et al. Feasibility of quantifying SDC2 methylation in stool DNA. Clin Epigenetics. 2017;9:126. Open access
Fan X et al. External quality assessment for methylated SDC2. Clin Chem Lab Med. 2022;60(10):1570-1576. PubMed
Yue C et al. Clinical study & meta-analyses on SDC2 methylation. Front Med. 2022;9:753545. Open access
Qin B et al. Real-world retrospective screening with fecal SDC2. Cancer Pathogenesis & Therapy. 2025;3(1):60-67. Elsevier
Wang X et al. SDC2 test vs FIT/CEA (hospital cohort). Am J Transl Med. 2021;5(1):37-50. PDF

References

[1]American Society for Gastrointestinal Endoscopy (ASGE). Deciding on a CRC Screening Test. 2022. PDF. • [2]BowelScreen Programme Report 2022–2023. PDF. • [3]Wang X, Xu P, Shen H, et al. A novel stool‑based SDC2 DNA methylation test is more robust than FIT and plasma CEA in detecting colorectal neoplasia in China. American Journal of Translational Medicine. 2021;5(1):37‑50. PDF. • [4]Wang J, Liu S, Wang H, et al. Robust performance of a novel stool DNA test of methylated SDC2 for colorectal cancer detection: a multicenter clinical study. Clinical Epigenetics. 2020;12:162. doi:10.1186/s13148-020-00954-x. • [5]Zhao S, He Z, Sui X, et al. Real‑world stool‑based syndecan‑2 methylation test improved detection of advanced colorectal neoplasia for colorectal cancer screening: a prospective, multicenter, community‑based study. Gastroenterology. 2024;167(3):611‑614.e7. PubMed. • [6]Kong X, Wu Q, Zhang Z, et al. Effectiveness of single‑target fecal DNA methylation test in regional mass screening for colorectal cancer and precancerous lesions in China. Gastroenterology Report. 2025;13:goaf029. doi:10.1093/gastro/goaf029.