- Design
- Prospective, blinded, multicentre diagnostic accuracy study
- Population
- 1,268 adults with cirrhosis; 46 with HCC on MRI
- Primary outcome
- Sensitivity and specificity versus ultrasound for HCC
- Effect
- Sensitivity 47.8% vs 28.3%; ≤2 cm 28.6% vs 0%; specificity 87.6% vs 93.9%
This prospective, blinded, multicentre study (published May 2026) compared the HelioLiver Dx multi-analyte cell-free DNA blood test with ultrasound for detecting hepatocellular carcinoma in 1,268 adults with cirrhosis. All had multiphasic MRI as the reference. HCC was found in 46 (3.6%), almost half of them 2 cm or smaller.
Sensitivity was 47.8% (95% CI 32.9 to 63.1) for the blood test and 28.3% (16.0 to 43.5) for ultrasound. For lesions of 2 cm or less, the blood test detected 28.6% and ultrasound none. Specificity was 87.6% for the blood test and 93.9% for ultrasound.
Ultrasound surveillance misses many small cancers, and adherence is poor. A blood test is easier to do but still missed half of all HCC and will generate more false positives needing MRI. It is not available in India and is not yet in guidelines.
- Continue 6-monthly ultrasound with or without AFP for HCC surveillance in cirrhosis.
- Ultrasound missed every HCC of 2 cm or less in this study; consider MRI or CT where ultrasound is technically poor.
- Blood-based tests are not yet a substitute for imaging.
- Poor adherence is the biggest failure point; build recall systems for surveillance.
Why it matters
It confirms how often ultrasound misses early HCC in cirrhosis.
Don't overread it
The test was compared with a single ultrasound, not a surveillance programme, and has not been shown to improve survival.
The statistics, in plain English
With only 46 cancers, sensitivity estimates have wide confidence intervals. At 87.6% specificity, about one in eight people without cancer would test positive and need further imaging.
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