Systematic review evaluates diagnostic accuracy of cfDNA in breast cancer, indicating potential as an adjunctive tool.
INTRODUCTION: We evaluated the diagnostic accuracy of circulating cell-free DNA (cfDNA) and circulating tumor DNA (ctDNA) compared to tissue biopsy in breast cancer across three assay modalities. METHODS: We searched PubMed, Scopus, and Cochrane for studies published from January 2014 to March 2026. Bivariate random effects models pool sensitivity, specificity, and area under the curve (AUC). Registered under (CRD420261333264). RESULTS: ) occurred across all subgroups. Overall certainty was low, due to case-control designs and inconsistency. CONCLUSION: While cfDNA cannot replace tissue biopsies, current pooled estimates demonstrate high specificity, suggesting promising potential as an adjunctive diagnostic tool. Quantitative assays show the greatest potential for optimizing patient triage. However, the overall low certainty of evidence highlights an urgent need for standardized prospective studies.
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