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The study behind the first approved blood test for bowel cancer screening: it found 83% of cancers but only 13% of advanced polyps.
Among 7,861 evaluable participants (NEJM 2024), the cfDNA blood test had 83.1% sensitivity for colorectal cancer, 13.2% sensitivity for advanced precancerous lesions, and 89.6% specificity for advanced neoplasia; sensitivity was 87.5% for stage I-III cancers. The FDA approved Shield on 26 July 2024 (PMA P230009) and Medicare covers it every three years. The low sensitivity for precancerous lesions means the test detects rather than prevents cancer, and guideline bodies rank it below colonoscopy, FIT and stool DNA.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
44,467 enrolled.
Shares Shield, Guardant Health, Early-onset colorectal cancer (under 50), Liquid biopsy (ctDNA).
Shares Sensitivity and specificity, Shield, Cell-free DNA (cfDNA), Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood).
Shares Sensitivity and specificity, Cell-free DNA (cfDNA), Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood), Liquid biopsy (ctDNA).
Shares Multitarget stool RNA test (ColoSense), Sensitivity and specificity, Shield, Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood).
Shares Multitarget stool RNA test (ColoSense), Shield, Early-onset colorectal cancer (under 50), Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood).
Shares Multitarget stool RNA test (ColoSense), Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood), Colorectal cancer.
Shares Sensitivity and specificity, Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood), Colorectal cancer.
Shares Early-onset colorectal cancer (under 50), Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood), Colorectal cancer.