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The study behind the second approved blood test for bowel cancer screening: the test found about four in five cancers and kept false alarms low, but like Shield it missed most advanced polyps, which is why guidelines still rank blood tests below colonoscopy and stool tests.
PREEMPT CRC (NCT04369053; organisation id FRNM-004) was a prospective, multicentre, cross-sectional observational study of Freenome's investigational blood-based circulating tumour DNA and protein test for colorectal cancer screening. Asymptomatic average-risk adults aged 45 to 85 had blood drawn before a standard-of-care screening colonoscopy at 201 centres across 49 US states and the United Arab Emirates between May 2020 and April 2022. Participants, staff and pathologists were blinded to the blood test result, and laboratory testing was blinded to colonoscopy findings. The primary endpoints were sensitivity for colorectal cancer and specificity, negative predictive value and positive predictive value for advanced colorectal neoplasia; the secondary endpoint was sensitivity for advanced precancerous lesions.
In the evaluable cohort of 27,010 participants (JAMA 2025), sensitivity for colorectal cancer was 79.2 percent (57 of 72; 95 percent CI 68.4 to 86.9) and specificity for advanced colorectal neoplasia was 91.5 percent (22,306 of 24,371; 91.2 to 91.9). Negative and positive predictive values for advanced colorectal neoplasia were 90.8 percent and 15.5 percent. All primary endpoints met their prespecified acceptance criteria. Sensitivity for advanced precancerous lesions was 12.5 percent (321 of 2,567; 11.3 to 13.8) and did not meet its acceptance criterion.
ClinicalTrials.gov lists an actual enrolment of 48,995 for the completed study. The FDA approved the test as SimpleScreen CRC on 24 July 2026 for average-risk adults aged 45 and older; Abbott holds US commercial rights. The registry study type is observational, which is why the interventional phase 2 and 3 pass never attached it to the product.
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.
48,995 enrolled.
57 of 72 cancers; 95% CI 68.4 to 86.9
Source22,306 of 24,371; 95% CI 91.2 to 91.9
Source321 of 2,567; 95% CI 11.3 to 13.8; did not meet the prespecified acceptance criterion
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Sensitivity for colorectal cancerprimary | Freenome blood test (SimpleScreen CRC) | 27,010 | 79.2% | - | - | link |
| Specificity for advanced colorectal neoplasiaprimary | Freenome blood test (SimpleScreen CRC) | 27,010 | 91.5% | - | - | link |
| Sensitivity for advanced precancerous lesions (secondary) | Freenome blood test (SimpleScreen CRC) | 27,010 | 12.5% | - | - | link |
Shares SimpleScreen CRC, Sensitivity and specificity, Screening, Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood).
Shares SimpleScreen CRC, Freenome, Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood), Colorectal cancer.
Shares Sensitivity and specificity, Cell-free DNA (cfDNA), Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood), Liquid biopsy (ctDNA).
Shares Sensitivity and specificity, Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood), DNA methylation profiling, Colorectal cancer.
Shares SimpleScreen CRC, Freenome, Screening, Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood).
Shares Sensitivity and specificity, Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood), DNA methylation profiling, Colorectal cancer.
Shares DNA methylation profiling, Liquid biopsy (ctDNA), Colorectal cancer.
Shares DNA methylation profiling, Liquid biopsy (ctDNA), Colorectal cancer.