Singlera Genomics and Fudan University's Zhongshan Hospital have published groundbreaking results from their large-scale multi-center GUIDE prospective cohort study, demonstrating that the GutSeer® DNA methylation-based assay can non-invasively detect five major types of gastrointestinal cancer at early stages using a simple blood test. The peer-reviewed manuscript, published in the journal Molecular Cancer, represents a significant advancement in early cancer detection technology.
Study Design and Performance
The GUIDE study (NCT05431621) was a landmark multi-center collaboration that prospectively enrolled individuals from inpatient and outpatient medical centers. Participants were stratified based on radiological or pathological assessments into non-cancerous, advanced precancerous lesion, and cancerous groups following standard-of-care cancer diagnostic guidelines.
The GutSeer® assay demonstrated impressive performance metrics, achieving 81.5% sensitivity and 94.4% specificity for cancer detection. Notably, 66.4% of cancer patients in the cohort were early-stage (stage I/II), highlighting the assay's capability to detect cancers when treatment is most effective. The test was also able to determine the tissue-of-origin of cancer in 80.7% of cases and detect between 21.4% to 47.1% of precancerous lesions, depending on cancer type.
Superior Performance Compared to Alternative Methods
In direct comparison studies within the same cohort, the GutSeer® assay outperformed a low-pass whole genome sequencing (WGS) fragmentomics assay, demonstrating an area under the curve (AUC) of 0.963 versus 0.887, respectively. This superior performance was achieved at a lower testing cost, making the technology more accessible for widespread screening applications.
Clinical Significance and Cancer Types
The assay targets five high-incidence and high-mortality gastrointestinal cancers: liver cancer, gastric cancer, colorectal cancer, esophageal cancer, and pancreatic cancer. Professor Zhou Jian from Zhongshan Hospital emphasized the clinical significance of these results, stating that "this world first prospective cohort-validated early screening technology for multiple cancers of the digestive tract has successfully achieved high-precision, non-invasive early detection and tissue traceability."
Technology and Validation
The GutSeer® assay utilizes DNA methylation-based cancer detection technology and has previously been validated as a laboratory-developed test (LDT) in the United States and received the CE-IVD mark in the European Union. The technology processes blood samples to identify methylation patterns associated with gastrointestinal cancers.
Multi-Institutional Collaboration
The GUIDE study represents a comprehensive collaboration between Singlera Genomics and multiple prestigious medical institutions, including Zhongshan Hospital, Hubei Cancer Hospital, Xuhui Central Hospital, Xiangya Medical Laboratory, The First Hospital of Putian, and Changhai Hospital. This multi-center approach strengthens the validity and generalizability of the study results.
Market Advancement
Singlera Genomics is actively advancing efforts to bring GutSeer® to market across the United States, European Union, and China through partnerships with cancer centers, health systems, and clinical laboratories worldwide. The company's approach focuses on seamless integration into existing digestive tract diagnosis and treatment processes, positioning the technology for large-scale population screening applications.
The publication of these results follows previous presentations at the ASCO Annual Meeting in June 2025, demonstrating the continued scientific validation of this innovative early detection technology.
