PREEMPT CRC Study

The largest clinical validation study for a blood-based CRC screening test

The PREEMPT CRC study (NCT04369053) was a prospective multi-center observational study to validate a blood-based test for the early detection of colorectal cancer (CRC) by collecting blood samples from average-risk participants who were undergoing a routine screening colonoscopy.

Study results

In a landmark study recently published in JAMA, Freenome’s blood test was proven accurate in screening for CRC.¹

PREEMPT CRC met acceptance criteria for specificity and sensitivity

2020 U.S. Census-Adjusted Clinical Performance

Test Sensitivity by CRC Stage

Test Sensitivity for CRC by Lesion Size and Location

Study recruitment

LARGE

REPRESENTATIVE

DIVERSE

>40kparticipants (of average risk for CRC)

Study design

In the PREEMPT CRC study, blood draw results were clinically validated against colonoscopy-confirmed outcomes

Study population

Adults 45-85 years of age with average risk for CRC

No personal history of cancer, colorectal adenoma, or inflammatory bowel disease
No hereditary gastrointestinal cancer syndrome
No high-risk family history of CRC
Screen-eligible

How our screening platform works

Freenome developed a multiomics platform that analyzes genomic, epigenomic, and proteomic biomarkers to detect cancer-specific signals in the bloodstream, including tumor-derived cell-free DNA (cfDNA).

The CRC screening blood test was built on this platform and applies an AI/ML-based model to detect specific methylation signatures in cfDNA at single base resolution.

Why it matters

CRC is the world’s second deadliest cancer, with more than 50,000 deaths per year in the U.S. alone. When CRC is detected and treated before it spreads, the survival rate exceeds 90%.² Yet more than two out of five U.S. adults of screening age are not current with recommended CRC screening.³ Barriers such as discomfort, preparation or access often lead to low adherence rates. That’s why our first test is focused on CRC, to provide a less invasive, more accessible screening option.

^aStage was reported for all except one CRC case, which was deteced by the blood test. Stages were defined by the American Joint Committee on Cancer Staging System, 8th edition. CRC, colorectal cancer.

^bLesion size was reported for all except two CRC cases.

References

1. Shaukat A, Burke CA, Chan AT, et al. Clinical validation of a circulating tumor DNA–based blood test to screen for colorectal cancer. JAMA. 2025;334(1):56-63. doi:10.1001/jama.2025.7515

2. Siegel RL, Krat§er TB, Giauinto AN, Sung H, Jemal A. Cancer statistics, 2025. CA Cancer J Clin. 2025;75(1):10-45. doi:10.3322caac.21b71

3. Siegel RL, Wagle NS, Cercek A, Smith RA, Jemal A. Colorectal cancer statistics, 2023. CA Cancer J Clin. 2023;73(3):233-254. doi:10.3322caac.21772

PREEMPT CRC Study

The largest clinical validation study for a blood-based CRC screening test

Study results

Test Sensitivity by CRC Stage

Test Sensitivity for CRC by Lesion Size and Location

Study recruitment

LARGE

REPRESENTATIVE

DIVERSE

>40kparticipants (of average risk for CRC)

Study design

In the PREEMPT CRC study, blood draw results were clinically validated against colonoscopy-confirmed outcomes

Study population

Adults 45-85 years of age with average risk for CRC

How our screening platform works

Why it matters

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