FRIDAY, March 15, 2024 (HealthDay News) -- A cell-free DNA (cfDNA) blood-based test has sensitivity of 83.1 percent for detection of colorectal cancer and specificity of 89.6 percent for any advanced neoplasia, according to a study published in the March 14 issue of the New England Journal of Medicine.
Daniel C. Chung, M.D., from Massachusetts General Hospital and Harvard Medical School in Boston, and colleagues examined the performance characteristics of a cfDNA blood-based test in a population eligible for colorectal cancer screening. The coprimary outcomes were sensitivity for colorectal cancer and specificity for advanced neoplasia relative to screening colonoscopy.
The clinical validation cohort included 10,258 individuals; 7,861 were evaluable. The researchers found that 83.1 and 16.9 percent of the participants with colorectal cancer detected by colonoscopy had a positive and negative cfDNA test, respectively, indicating sensitivity of 83.1 percent for detection of colorectal cancer. The sensitivity for stage I, II, or III colorectal cancer and for advanced precancerous lesions was 87.5 and 13.2 percent, respectively. Overall, 89.6 percent of the participants without any advanced colorectal neoplasia identified on colonoscopy had a negative cfDNA blood-based test, while 10.4 percent had a positive test, indicating specificity of 89.6 percent for any advanced neoplasia. Specificity was 89.9 percent for negative colonoscopy.
"Evaluation of participant adherence to this cfDNA blood-based test in various clinical settings is warranted and is an area of active investigation, especially given that participant adherence is affected by many factors beyond the test availability," the authors write.
The study was funded by Guardant Health.
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