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Cell-Free DNA Analysis With Clinicopathologic Factors for Early Detection and Refining Lymph Node Metastasis Risk in
Tatsuro Murano1, Hiroaki Ikematsu1, Nobuhisa Matsuhashi2
1Department of Gastroenterology and Endoscopy, National Cancer Center Hospital East, Chiba, Japan.
JCO Precision Oncology
|July 1, 2026
Summary
A new blood test using cell-free DNA (cfDNA) shows high accuracy for detecting colorectal cancer (CRC). This noninvasive test can improve early diagnosis and aid in treatment decisions for CRC and precancerous lesions.
Area of Science:
- Oncology
- Molecular Diagnostics
- Biomarkers
Background:
- Colorectal cancer (CRC) remains a leading cause of cancer death worldwide.
- Early detection of CRC and advanced precancerous lesions (APLs) is crucial for improving patient outcomes.
- Noninvasive diagnostic methods, such as blood-based assays, are highly sought after for CRC screening.
Purpose of the Study:
- To evaluate the diagnostic performance of the Shield blood test, a cell-free DNA (cfDNA) assay, for detecting CRC and APLs.
- To assess the clinical utility of the cfDNA test, particularly in early-stage CRC.
- To investigate the test's ability to aid in risk stratification and clinical decision-making.
Main Methods:
- A prospective, multicenter study involving 451 patients with confirmed CRC or APLs.
- Analysis of blood samples using the Shield cfDNA test (Guardant Health).
- Assessment of test sensitivity across different CRC stages and for APLs, and correlation with clinicopathologic factors in early-stage CRC.
Main Results:
- The cfDNA test demonstrated 87.9% overall sensitivity for CRC, with 71.2% for stage I and 97.4% for stages II-IV.
- Sensitivity for APLs was 37.0%.
- In stage I CRC, test positivity correlated with tumor depth. The test showed 100% sensitivity for detecting lymph node metastasis in T1 CRC and higher specificity for predicting LNM compared to standard criteria.
Conclusions:
- The Shield cfDNA blood test exhibits robust diagnostic performance for CRC detection.
- This assay has the potential to enhance risk stratification and personalize clinical decision-making.
- The test may be particularly valuable in managing T1 CRC by improving the prediction of lymph node metastasis.
