Singlera Genomics and Partners publish results from GUIDE prospective cohort study demonstrating blood-based early detection of gastrointestinal cancers using DNA methylation-based GutSeer assay

SAN DIEGO and SHANGHAI, China, June 17, 2025 (GLOBE NEWSWIRE) -- Singlera Genomics, a biotechnology company focused on non-invasive early cancer detection, and Fudan University’s Zhongshan Hospital, a premier highly ranked public hospital in China, today announced the publication of a peer-reviewed manuscript in the journal Molecular Cancer demonstrating the results of the large-scale multi-center GUIDE prospective cohort study, showing that Singlera’s GutSeer^® assay can non-invasively detect five major types of gastrointestinal cancer at early stage using a simple blood test. Some results from the study had previously been presented at the ASCO Annual Meeting held June 2025 in Chicago, Illinois.

The GUIDE study (NCT05431621) represents a landmark multi-center collaboration jointly led by Singlera Genomics and Zhongshan Hospital, in close partnership with Hubei Cancer Hospital, Xuhui Central Hospital, Xiangya Medical Laboratory, The First Hospital of Putian, and Changhai Hospital. The study prospectively enrolled individuals and collected blood samples from inpatient and outpatient medical centers, and participants were sequentially stratified based on radiological or pathological assessments following standard-of-care cancer diagnostic guidelines into non-cancerous, advanced precancerous lesion, and cancerous groups. Blood samples were processed using Singlera’s GutSeer^® DNA methylation-based cancer detection assay, which has previously been validated as a laboratory-developed test (LDT) in the US and received the CE-IVD mark in the European Union.

In the study, even with 66.4% of cancer patients in the cohort being early-stage (stage I/II), the GutSeer^® assay achieved a sensitivity of 81.5% and specificity of 94.4% for cancer detection. GutSeer^® was also able to determine the tissue-of-origin of cancer in 80.7% of cases, and detect 21.4% to 47.1% of precancerous lesions (dependent on cancer type). In this same cohort, the GutSeer^® assay outperformed a low-pass WGS fragmentomics assay, demonstrating an AUC of 0.963 versus an AUC of 0.887, respectively. These results highlight the potential of GutSeer^® to detect early-stage and pre-cancerous lesions and show that GutSeer’s highly compact panel can achieve superior performance at a lower testing cost, offering hope for early intervention and improved patient outcomes.

“The release of GutSeer^®'s research results marks a breakthrough step in the field of early screening of digestive tract cancer,” said Professor Zhou Jian from Zhongshan Hospital. “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 of five high-incidence and high-mortality gastrointestinal cancers: liver cancer, gastric cancer, colorectal cancer, esophageal cancer, and pancreatic cancer. The success of GutSeer^® lies not only in its excellent performance, but also in the clinical orientation of its design, which is designed for a specific group of gastrointestinal cancers, focuses on clear clinical needs, and can be seamlessly integrated into existing digestive tract diagnosis and treatment processes, laying a solid foundation for large-scale population screening in the future.”

The GUIDE study is a milestone in transforming early cancer detection from concept to reality. Its success was made possible by the combined dedication of clinical investigators, biotechnology experts, data scientists, and academic collaborators spanning multiple institutions and regions. Singlera 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.

https://clinicaltrials.gov/study/NCT05431621

Singlera Genomics Inc. (www.singlera.com)

Singlera Genomics Inc., a globally operating enterprise specializing in non-invasive genetic diagnosis, was established in July 2014. With a presence spanning across continents, the company boasts research and development centers along with business operations worldwide. Singlera is at the forefront of innovation with its proprietary technologies in single-cell sequencing, DNA methylation, and bioinformatics, making significant strides in the global field of genomics.

Zhongshan Hospital, affiliated with Fudan University (https://www.fudan.edu.cn/en/144/list.htm)

Zhongshan Hospital is a major teaching hospital founded in 1937 and affiliated with the Ministry of Health of China. It was then the first large hospital run by the Chinese. Through 76 years of development, Zhongshan Hospital now covers an area of 95,892 m², and has 1,700 beds serving 84,000 inpatients and more than 3,000,000 outpatients and emergency cases. Among its 3,433 medical staff members are 437 professors and associate professors, 1,219 physicians, 1,340 nurses, 401 technicians, 1 member of the Chinese Academy of Sciences, and 2 members of the Chinese Academy of Engineering. Zhongshan Hospital places patient needs as the top priority and is dedicated to providing the highest standard of clinical care for all people.

Contacts

Media Contact
Alan Fung, Singlera Genomics
858.732.0061
alan.fung@singleragenomics.com

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