# ECLIPSE (Shield blood test)

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

## TL;DR

The study behind the first approved blood test for bowel cancer screening: it found 83% of cancers but only 13% of advanced polyps.

## Summary

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.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-10
- Registry id: NCT04136002
- Phase: observational
- Setting: Prospective study of the Shield cell-free DNA blood test against screening colonoscopy in average-risk adults aged 45 to 84
- Sponsor: Guardant Health
- Enrolled: 44467
- Result: Sensitivity 83.1% for colorectal cancer, 13.2% for advanced precancerous lesions; specificity 89.6%.
- Outcomes: Sensitivity for colorectal cancer: Shield cfDNA blood test 83.1%; Specificity for advanced neoplasia: Shield cfDNA blood test 89.6%

## Sources

- ClinicalTrials.gov NCT04136002: https://clinicaltrials.gov/study/NCT04136002
- ECLIPSE (NEJM 2024): https://doi.org/10.1056/NEJMoa2304714
- FDA PMA P230009: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230009

## Connected records

- cancers: [Colorectal cancer](https://onco.cc/cancers/colorectal/), [Early-onset colorectal cancer (under 50)](https://onco.cc/cancers/early-onset-colorectal/)
- technologies: [Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood)](https://onco.cc/technologies/colorectal-screening/), [Liquid biopsy (ctDNA)](https://onco.cc/technologies/liquid-biopsy/), [Multitarget stool RNA test (ColoSense)](https://onco.cc/technologies/multitarget-stool-rna-test/)
- drugs: [Shield](https://onco.cc/drugs/shield/)
- companies: [Guardant Health](https://onco.cc/companies/guardant-health/)
- terms: [Cell-free DNA (cfDNA)](https://onco.cc/terms/cfdna/), [Sensitivity and specificity](https://onco.cc/terms/sensitivity-specificity/)
- key papers: [A Cell-free DNA Blood-Based Test for Colorectal Cancer Screening](https://onco.cc/key-papers/paper-eclipse-shield-n-engl-j-med-2024/)
- roadmaps: [ctDNA tests roadmap: from a curiosity in plasma to blood tests that decide treatment](https://onco.cc/roadmaps/ctdna-tests/)

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