Новый анализ крови с высокой точностью выявляет рак толстой кишки и предраковые образования

A blood-based assay that incorporates both cell-free and exosomal miRNA has achieved high sensitivity and specificity for the detection of colorectal cancer (CRC) and advanced adenomas, according to research published in The Lancet Gastroenterology & Hepatology. The results, which come from a case-controlled biomarker study, support continued investigation of the noninvasive assay in large-scale prospective studies, researchers suggested. “This work establishes a conceptual and methodological framework for future blood-based screening tools,” they wrote. The Detection of colorectal NEoplasias in Blood (DENEB) study (NCT06342440) is an international, retrospective biomarker diagnostic accuracy study. The researchers developed and evaluated a blood-based cell-free and exosomal miRNA panel for detecting early-stage CRC and advanced adenomas. The study included 1613 adults at average risk for CRC undergoing routine screening with colonoscopy. The researchers included 848 individuals in the biomarker discovery cohorts, where candidate miRNAs were identified through small RNA sequencing. Another 765 participants were part of the 2 training and testing clinical cohorts. Reverse transcription quantitative PCR (RT-qPCR) was used to measure biomarkers in the clinical cohorts. The researchers then employed machine learning to build models and establish diagnostic thresholds in the training cohort, and evaluated the thresholds in the testing cohort. Using the dual-model test among the 230 participants in the testing cohort, overall sensitivity was 91% for any-stage CRC and 92% for stage I-III CRC. Sensitivity for colonoscopy-detected advanced adenomas was 81%. “Notably, the test identified all stage IV cancers,” the researchers reported. Overall specificity was 85% for individuals without advanced colorectal neoplasia. “The assay met its benchmarks for overall specificity and sensitivity in both any-stage colorectal cancer and stage I-III colorectal cancer, with the lower 95% CI bounds matching or exceeding the targets,” the researchers wrote. “However, while advanced adenoma point sensitivity was 81%, the lower bound of its 95% CI fell below the 80% threshold.” The researchers noted an ongoing debate about whether a lower statistical threshold for the advanced adenoma endpoint is “clinically acceptable,” given the extended window for malignant transformation. “These findings suggest that integrating precursor-lesion biology into biomarker discovery could improve the ability of blood-based tests to detect clinically relevant premalignant lesions,” the researchers concluded. “The present findings provide a rationale for advancing this assay into large-scale prospective studies to determine its performance, clinical utility, and potential role within population-based screening strategies.” Disclosures: This research was supported by the National Institutes of Health and the AIRC Foundation. The study authors reported having no conflicts of interest. Please see the original reference for complete disclosures. This article originally appeared on Cancer Therapy Advisor