# PREEMPT CRC

Source: https://onco.cc/trials/preempt-crc/  
OnCo record `preempt-crc` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Summary

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.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-24
- Also known as: FRNM-004; Prevention of Colorectal Cancer Through Multiomics Blood Testing
- Registry id: NCT04369053
- Phase: observational
- Setting: Prospective cross-sectional validation of the Freenome cell-free DNA and protein blood test against screening colonoscopy in asymptomatic average-risk adults aged 45 to 85
- Sponsor: Freenome Holdings
- Enrolled: 48995
- Result: Sensitivity 79.2% for colorectal cancer and specificity 91.5% for advanced colorectal neoplasia (n = 27,010 evaluable); all primary endpoints met; advanced precancerous lesion sensitivity 12.5% did not meet its criterion.
- Outcomes: Sensitivity for colorectal cancer: Freenome blood test (SimpleScreen CRC) 79.2%; Specificity for advanced colorectal neoplasia: Freenome blood test (SimpleScreen CRC) 91.5%; Sensitivity for advanced precancerous lesions (secondary): Freenome blood test (SimpleScreen CRC) 12.5%
- Replication: ECLIPSE (Shield, Guardant) reported 83 percent cancer sensitivity and 13 percent advanced-adenoma sensitivity for the first approved blood test in the same setting, so the two studies agree that blood tests find most cancers and few advanced polyps.

## Sources

- ClinicalTrials.gov NCT04369053: https://clinicaltrials.gov/study/NCT04369053
- JAMA 2025: https://doi.org/10.1001/jama.2025.7515

## Connected records

- cancers: [Colorectal cancer](https://onco.cc/cancers/colorectal/)
- technologies: [Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood)](https://onco.cc/technologies/colorectal-screening/), [DNA methylation profiling](https://onco.cc/technologies/methylation-profiling/), [Liquid biopsy (ctDNA)](https://onco.cc/technologies/liquid-biopsy/)
- drugs: [SimpleScreen CRC](https://onco.cc/drugs/simplescreen-crc/)
- companies: [Freenome](https://onco.cc/companies/freenome/)
- terms: [Cell-free DNA (cfDNA)](https://onco.cc/terms/cfdna/), [Screening](https://onco.cc/terms/screening/), [Sensitivity and specificity](https://onco.cc/terms/sensitivity-specificity/)
- key papers: [Clinical validation of a circulating tumor DNA-based blood test to screen for colorectal cancer (PREEMPT CRC)](https://onco.cc/key-papers/paper-preempt-crc-shaukat-jama-2025/)

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