ECLIPSE (Shield blood test)
The study behind the first approved blood test for bowel cancer screening: it found 83% of cancers but only 13% of advanced polyps.
Overview
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.
- 83.1 out of 100 people reached this endpoint with Shield cfDNA blood test.
- 89.6 out of 100 people reached this endpoint with Shield cfDNA blood test.
- There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
- This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.
- These results apply to the people the trial enrolled: Prospective study of the Shield cell-free DNA blood test against screening colonoscopy in average-risk adults aged 45 to 84. People in a different situation may not see the same effect.
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.
22,877 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Sensitivity for colorectal cancerprimary | Shield cfDNA blood test | — | 83.1% | — | — | link |
| Specificity for advanced neoplasiaprimary | Shield cfDNA blood test | — | 89.6% | — | — | — |
Pages like this
not linked directly; found by shared links- ProductSimpleScreen CRC
Shares Sensitivity and specificity, Cell-free DNA (cfDNA), Shield, Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood).
- IdeaOffer the blood test for bowel cancer only to people who refuse stool tests or colonoscopy
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- CompanyFreenome
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